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Context: Glucocorticoids (GCs) are widely used for their anti-inflammatory and immunosuppressive properties. Their effect on bone health is predominantly negative by decreasing bone formation and increasing risk of fractures., Objective: This work aimed to quantify the short- and long-term changes in total hip bone mineral density (THBMD) after initiating systemic GC treatment in previously GC treatment-naive adults without bone protective agents., Methods: An observational study was conducted using THBMD data from dual-energy x-ray absorptiometry (DXA). Individuals were stratified by sex and tertiles of GC exposure. Individuals not GC-exposed served as a reference group. Routine-care DXA scans were obtained from the main public hospitals servicing the Island of Funen in Denmark. A total of 15 099 adults underwent routine DXA at Odense University Hospital between 2006 and 2021. Data were enriched with Danish national registers. Intervention included systemic GCs (observational data). The short-term outcome included annualized THBMD changes between first 2 DXA scans. The long-term outcome included greater than 5% annualized THBMD loss over a 10-year follow-up., Results: Strong associations between GC exposure and THBMD loss was found for both outcomes, with larger losses in the middle and upper tertiles of GC exposure. The risk of experiencing greater than 5% annualized THBMD loss was elevated, especially in the first 2 years of initiating GC treatment. There is significant heterogeneity in THBMD responses, with approximately 1 in 5 patients experiencing no nominal bone loss despite receiving upper tertile levels of GC exposure., Conclusion: The findings confirm the association between initial GC exposure and significant bone loss. The heterogeneity in individual responses emphasizes the need for early monitoring and personalized approaches in managing bone health for patients undergoing GC treatment., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.)

Background: Breast cancer-related lymphedema (BCRL) is a debilitating sequela affecting up to 1 in 3 breast cancer survivors. Treatments are palliative and do not address the underlying lymphatic injury. Recent preclinical and nonrandomized studies have shown promising results using adipose-derived regenerative cells (ADRCs) and lipotransfer in alleviating BCRL through regeneration of lymphatic tissue. However, no randomized controlled trial has been performed in an attempt to eliminate a placebo effect., Methods: This randomized, double-blind, placebo-controlled trial included patients with no-option, persistent disabling unilateral BCRL. Patients were randomly assigned in a 1:1 ratio to receive either autologous ADRCs (4.20×10 7 ± 1.75×10 7 cells) and 30-cc lipotransfer or placebo (saline) to the axilla. The primary outcome was a change in BCRL volume 1 year after treatment. Secondary outcomes included changes in quality of life, indocyanine green lymphangiography stage, bioimpedance, and safety., Results: Eighty patients were included, of whom 39 were allocated to ADRCs and lipotransfer treatment and 41 to placebo treatment. Baseline characteristics were similar in the groups. One year after treatment, no objective improvements were observed in the treatment or placebo groups. In contrast, significant subjective improvements were noted for both the treatment and placebo groups., Conclusions: This trial failed to confirm a benefit of ADRCs and lipotransfer in the treatment of BCRL. These nonconfirmatory results suggest that ADRC and lipotransfer should not be recommended for alleviating BCRL. However, the authors cannot exclude that repeated treatments or higher doses of ADRCs or lipotransfer could yield a clinical effect., Clinical Question/level of Evidence: Therapeutic, I., (Copyright © 2024 by the American Society of Plastic Surgeons.)

Background: One in three women and one in five men over the age of 50 will experience an osteoporotic fracture. Vertebral fractures can be very painful, affect patients' daily function, and in severe cases require hospitalization. Traditionally, fracture pain is treated conservatively with analgesics, and bracing. Vertebral augmentation, also known as vertebroplasty, has been used during the last three decades as a minimally invasive treatment option for vertebral compression fractures, but the evidence base for its efficacy is weak. We describe a double-blind randomized sham-controlled clinical trial to assess the impact of vertebroplasty on self-reported clinical outcomes in patients with painful osteoporotic vertebral compression fractures and vertebral oedema., Methods: Two hundred and forty patients with painful osteoporotic vertebral fractures and MRI verified oedema will be randomized in a prospective, double-blind, single-center, clinical trial to either vertebroplasty or a sham procedure, with the possibility of crossover 12 weeks after randomization and operation. The primary outcome will be difference in self-reported pain 12 weeks after treatment between the vertebroplasty and sham group. Secondary outcomes will be patient-reported disability, health-related quality of life, societal costs of treatment and complications. Analysis will be based on intention-to-treat. Repeated measures ANCOVA with baseline ODI, Numerical Pain Rating Scale, EQ-5D-5 L, and number of levels involved as co-variates will be performed., Discussion: With an aging population, the prevalence of osteoporosis and related complications such as vertebral compression fractures is expected to increase. Therefore, there is a growing need for evidence-based fracture treatments. This study fills a gap in the evidence base for treatment of painful osteoporotic vertebral fractures and will likely influence future treatment guidelines., Trial Registration: The study has been evaluated and approved by the Regional Committees on Health Research for Southern Denmark October 9 2023 (Projekt-ID S-20230058) and the Danish Data Protection Agency 23/40,938. The protocol has been registered at ClinicalTrials.gov with trial registration number NCT06141187 November 21, 2023., Competing Interests: Declarations. Ethics approval and consent to participate: The study will be performed according to the Declaration of Helsinki and the Danish Code of Conduct for Research Integrity. The study has been approved by the Regional Committees on Health Research for Southern Denmark project-ID S-20230058. Further the project has been submitted to and approved by the Region of Southern Denmark and listed in the internal record. Permission from the Institutional Review Board of the Spine Centre of Southern Denmark has been obtained, journal no. 02/2023. Participation in the study is completely voluntary and can only take place after receiving both oral and written information about the study and signing a written consent. Patient information adheres to format requirements from the health research ethics committees and EU legislation. At any time during the study, the participants can withdraw their consent, and this will not affect the right to any current or future treatment. The participants are entitled to bring a member of the family or a friend to the informative interview and will be given several days from study information by phone and written information send by mail to consider participation. The informed consent form will be signed by all participating patients and stored at the Spine Surgery and Research unit, Kolding. A digital copy of the form will be added to the electronic patient records accessible at sundhed.dk. Consent for publication: A copy of the consent form that patients need to sign for study participation, along with a lay summary of the protocol, can be found on the following website: Permission to extract and publish data from hospital records will be obtained from the patients. Consent to use patient-reported information from the DaneSpine database is obtained electronically prior to patients completing the questionnaires. Patients who do not consent will not be included in the trial. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences following guidance from the SPIRIT guidelines. Trial status: Protocol 101528 version 3.1, date 02.10.23. Recruitment initiated 01.01.2024. Recruitment expected completed 31.12.2028. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Study Design: Register-based cohort study based on linked data from multiple national registries., Objective: To describe the sociodemographic and health characteristics of individuals in Denmark with osteoporotic vertebral fractures (OVF) and analyze time trends. The study compares labor market participation and comorbidities between OVF patients and a matched control group without these fractures., Summary of Background Data: The incidence and characteristics of OVF patients in Denmark are not well-documented. Multiple national health and economic registries enable linking of individual patient data, providing new insights., Methods: We identified individuals with hospital-diagnosed vertebral compression fractures from 2010 to 2018 using the Danish National Patient Register. A control group was matched by sex, age, and municipality. Work status prior to OVF was categorized as employed, on paid sickness benefit, in early retirement, or on old-age pension. Comorbidities were analyzed based on hospital diagnoses within 10 years prior to the fracture., Results: During 2010 to 2018, 20.262 individuals had a hospital contact with an OVF. Sixty-four percent were women and the mean age was 73.6 (SD 12.4) years. OVF incidence increased from 86 in 2010 to 142 per 100,000 persons in 2018. In 2018, the regional incidence ranged from 120 to 154 per 100,000. More than a fifth of the patients were working prior to the fracture, while 77% were in early retirement or old-age pension. The population with OVF had more comorbidities than the matched comparison group., Conclusion: The incidence of hospital-diagnosed OVFs has risen over the last decade, with regional differences. Notably, over 20% of OVF patients were still employed, highlighting the socioeconomic impact of this condition., Competing Interests: Conflicts of interest: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Reduced physical function caused by bone destruction, pain, anemia, infections, and weight loss is common in multiple myeloma (MM). Myeloma bone disease challenges physical exercise. Knowledge on the effects and safety of physical exercise in newly diagnosed patients with MM is limited. In a randomized, controlled trial, we studied the effect of a 10-week individualized physical exercise program on physical function, physical activity, lean body mass (LBM), bone mineral density (BMD), quality of life (QoL), and pain in patients newly diagnosed with MM. Lytic bone disease was assessed, and exercise was adjusted accordingly. Primary outcome: knee extension strength. Secondary outcomes: Six-Minute-Walk-Test, 30-s Sit-to-Stand-Test (SST), grip strength, level of physical activity, LBM, BMD, QoL, and pain. Measurements were conducted pre- and post-intervention, and after 6 and 12 months. We included 100 patients, 86 were evaluable; 44 in the intervention group (IG) and 42 in the control group (CG). No statistically significant differences between groups were observed. Knee extension strength declined in the IG (p = .02). SST, aerobic capacity, and global QoL improved in both groups. Pain decreased consistently in the IG regardless of pain outcome. No significant safety concerns of physical exercise in newly diagnosed patients with MM were observed., (© 2024 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.)

Background: Osteoporotic fractures pose a growing public health concern. Osteoporosis is underdiagnosed and undertreated, highlighting the necessity of systematic screening programs. We aimed to evaluate the effectiveness of a two-step population-based osteoporotic screening program., Methods: This ten-year follow-up of the Risk-stratified Osteoporosis Strategy Evaluation (ROSE) randomized trial tested the effectiveness of a screening program utilizing the Fracture Risk Assessment Tool (FRAX) for major osteoporotic fractures (MOF) to select women for dual-energy x-ray absorptiometry (DXA) scan following standard osteoporosis treatment. Women residing in the Region of Southern Denmark, aged 65-80, were randomised (single masked) into a screening or a control group by a computer program prior to inclusion and subsequently approached with a mailed questionnaire. Based on the questionnaire data, women in the screening group with a FRAX value ≥15% were invited for DXA scanning. The primary outcome was MOF derived from nationwide registers. ClinicalTrials.gov: NCT01388244, status: Completed., Findings: All randomised women were included February 4, 2010-January 8, 2011, the same day as approached to participate. During follow-up, 7355 MOFs were observed. No differences in incidences of MOF were identified, comparing the 17,072 women in the screening group with the 17,157 controls in the intention-to-treat analysis (IRR 1.01, 0.95; 1.06). However, per-protocol, women DXA-scanned exhibited a 14% lower incidence of MOF (IRR 0.86, 0.78; 0.94) than controls with a FRAX value ≥15%. Similar trends were observed for hip fractures, all fractures, and mortality., Interpretation: While the ROSE program had no overall effect on osteoporotic fracture incidence or mortality it showed a preventive effect for women at moderate to high risk who underwent DXA scans. Hence the overall effect might have been diluted by those who were not at an intervention level threshold risk or those who did not show up for DXA. Using self-administered questionnaires as screening tools may be inefficient for systematic screening due to the low and differential screening uptake., Funding: INTERREG and the Region of Southern Denmark., Competing Interests: BA has received institutional research grants from UCB, Kyowa-Kirin and Pharmacosmos, personal consulting fees from UCB and Kyowa-Kirin, and speakers fees from Gedeon-Richter. APH has received Lecture honoraria from UCB, AMGEN, and Gideon Richter, Travel Grants from UCB, and grant to participate on a Data Safety Monitoring Board/Advisory Board from UCB and Gideon Richter. KEÅ has received lectures without fees from Amgen, UCB, and honoraria from Astellas Pharma. MKJ has received personal honoraria from Amgen, UCB, Abbvie, Besin Healthcare, and Sanofi and personal support for attending meetings/travel from UCB., (© 2024 The Author(s).)

Background: This study investigated changes in body weight, lean body mass (LBM), fat mass (FM), muscle strength and functional performance during radiation treatment in head and neck cancer (HNSCC) patients. Secondly, it investigated the impact of cisplatin-based chemoradiation (CCRT) on LBM loss compared with radiation alone., Methods: 48 patients (all tumor sites) received either 6 weeks of radiation alone ( n  = 16) with 66-68 Gy in 33-34 Fx, 5-6 Fx/week or CCRT, adding weekly cisplatin or carboplatin ( n  = 32). LBM and FM was evaluated using Dual-energy X-ray Absorptiometry bi-weekly from pre- to two weeks post-treatment. Maximal muscle strength (knee extension, leg - and chest press) and functional performance (stair climb, chair rise, and arm curl) were assessed pre- and post-treatment., Results: Body weight and LBM had declined significantly already week 2 into treatment and declined significantly further through week 4 and 6 before leveling off after week 6. Bi-weekly, from treatment start to week 2, 2-4, and 4-6, LBM declined 1.2 ± 0.4 kg ( p  = .002; 95% CI: 0.4;2.0), 2.0 ± 0.4 kg ( p  < .0001; 1.2;2.8) and 1.4 ± 0.4 kg ( p  = .001; 0.6;2.2). With a two-week delay, FM declined significantly from week 2-8. All measures of muscle strength declined significantly from pre- to post-treatment. Functional performance was unchanged. LBM loss from pre- to post-treatment was significantly associated with impaired muscle strength ( R 2 = 0.3-0.5). CCRT patients lost 3.1 ± 0.8 kg of LBM ( p  = .0001; 1.5;4.7) more from pre- to post-treatment compared with patients receiving radiation alone. Analyses adjusting for nimorazole, tumor stage, baseline BMI, mean radiation dose to constrictor muscles and oral cavity confirmed this., Conclusion: Accelerated and substantial LBM loss was already initiated within the first two weeks of treatment - before the onset of radiation-induced mucositis. LBM loss was associated with muscle strength impairment. Patients receiving CCRT experienced significantly larger LBM loss than patients receiving radiation alone. Registered on clinincaltrials.gov (Identifier: NCT05890859).

Objective: The aim of this study was to evaluate the accuracy of the Global Assessment of Pediatric Patient Safety (GAPPS) in order to identify patient safety incidents with patient harm or adverse events (AEs)., Methods: This is a cross-sectional, retrospective study of 240 records of hospitalized patients of both genders under 18 years of age, systematically and randomly selecting 10 charts of patients that meet the GAPPS criteria every 15 days from the 4,041 records of 2017., Results: The prevalence of AEs was 12.5%, i.e., detected in 30 out of 240 medical records. In total, 53 AEs and 63 harm were recorded, of which 53 (84.1%) were temporary and 43 AE (68.2%) were definitely or probably preventable. The presence of at least one trigger in a medical chart revealed 13 times greater chance of the occurrence of an AE, with sensitivity index of 48.5%, specificity of 100%, and accuracy of 86.5%., Conclusion: GAPPS was effective in detecting patient safety incidents with harm or AE.

Studies of primary hyperparathyroidism (PHPT) in multiple endocrine neoplasia type 2A (MEN 2A) shows divergence in frequency, disease definition, reporting of clinical characteristics and traces of selection bias. This is a nationwide population-based retrospective study of PHPT in MEN 2A, suggesting a representative frequency, with complete reporting and a strict PHPT definition. The Danish MEN 2A cohort 1930-2021 was used. Of 204 MEN 2A cases, 16 had PHPT, resulting in a frequency of 8% (CI, 5-12). Age-related penetrance at 50 years was 8% (CI, 4-15). PHPT was seen in the American Thyroid Association moderate (ATA-MOD) and high (ATA-H) risk groups in 62% and 38% of carriers, respectively. Median age at PHPT diagnosis was 45 years (range, 21-79). A total of 75% were asymptomatic and 25% were symptomatic. Thirteen underwent parathyroid surgery, resulting in a cure of 69%, persistence in 8% and recurrence in 23%. In this first study with a clear PHPT definition and no selection bias, we found a lower frequency of PHPT and age-related penetrance, but a higher age at PHPT diagnosis than often cited. This might be affected by the Danish RET p.Cys611Tyr founder effect. Our study corroborates that PHPT in MEN 2A is often mild, asymptomatic and is associated with both ATA-MOD and ATA-H variants. Likelihood of cure is high, but recurrence is not infrequent and can occur decades after surgery.

Purpose: This study aimed to compare changes in the bone turnover markers (BTMs)-C-terminal telopeptide of type I collagen (CTX-I) and procollagen I N-terminal peptide (PINP)-with changes in the bone microarchitecture, assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT), during treatment of patients with thyroid dysfunction., Methods: In women with newly diagnosed hypo- or hyperthyroidism, HR-pQCT variables, obtained from the tibia and the radius, were compared with BTMs. Data were collected at diagnosis and after at least 12 months of euthyroidism., Results: 73 women completed the study (hypothyroidism, n = 27; hyperthyroidism, n = 46). Among hyperthyroid patients, correlations were found between changes in BTMs and HR-pQCT variables, primarily for cortical variables in the tibia, i.e. cortical thickness (CTX-I, p < 0.001; PINP, p < 0.001), and volumetric bone mass density (vBMD) (CTX-I, p < 0.001; PINP, p < 0.001). Moreover, correlations between BTMs and estimated bone strength were found. In the hypothyroid subgroup, no significant findings existed after adjustment. Following treatment, less decrease in tibial vBMD was seen among patients with increasing CTX-I compared to those with a decreasing CTX-I level (p = 0.009). Opposite findings applied to PINP, as patients with decreasing PINP showed an increase in tibial vBMD, in contrast to a decline in this parameter among patients with increasing PINP (p < 0.001)., Conclusion: Changes in CTX-I and PINP correlated with HR-pQCT variables during the treatment of women with thyroid dysfunction. To some extent, these BTMs reflected the restoration of bone microarchitecture. CTX-I seems to be the most sensitive BTM in treatment-naïve thyroid diseases, while PINP is more useful for monitoring during treatment., Trial Registration Number: NCT02005250. Date: December 9, 2013., (© 2022. The Author(s), under exclusive licence to Italian Society of Endocrinology (SIE).)

Background: Bariatric surgery has adverse effects on the muscular-skeletal system with loss of bone mass and muscle mass and an increase in the risk of fracture. Zoledronic acid is widely used in osteoporosis and prevents bone loss and fracture. Bisphosphonates may also have positive effects on skeletal muscle. The aim of this study is to investigate the effects of zoledronic acid for the prevention of bone and muscle loss after bariatric surgery.  METHODS/DESIGN: This is a randomized double-blind placebo-controlled study. Sixty women and men with obesity aged 35 years or older will complete baseline assessments before randomization to either zoledronic acid (5 mg in 100 ml isotonic saline) or placebo (100 ml isotonic saline only) 3 weeks before surgery with Roux-en-Y-gastric bypass (RYGB) or sleeve gastrectomy (SG). Follow-up assessments are performed 12 and 24 months after surgery. The primary outcome is changes in lumbar spine volumetric bone mineral density (vBMD) assessed by quantitative computed tomography (QCT). Secondary bone outcomes are changes in proximal femur vBMD assessed by QCT. Changes in cortical and trabecular bone microarchitecture and estimated bone strength will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT). Cortical material bone strength at the mid-tibia diaphysis will be assessed using microindentation and fasting blood samples will be obtained to assess biochemical markers of bone turnover and calcium metabolism.  Secondary muscle outcomes include whole body lean mass assessed using dual-energy X-ray absorptiometry. Dynamometers will be used to assess handgrip, shoulder, ankle, and knee muscle strength. Short Physical Performance Battery, 7.6-m walking tests, 2-min walking test, and a stair climb test will be assessed as biomarkers of physical function. Self-reported physical activity level is assessed using International Physical Activity Questionnaire (IPAQ)., Discussion: Results from this study will be instrumental for the evidence-based care of patients undergoing bariatric surgery., Trial Registration: ClinicalTrials.gov NCT04742010. Registered on 5 February 2021., (© 2022. The Author(s).)

Background: Hypophosphatasia (HPP) is an autosomal recessive or dominate disease affecting bone mineralization, and adults with HPP are in risk to develop metatarsal stress fractures and femoral pseudofractures. Given to the scarce data on the bone quality and its association to the fracture risk in adults with HPP, this study aimed to evaluate bone turnover, bone strength and structure in adults with HPP., Methods: In this cross-sectional study, we included 14 adults with genetically verified HPP and 14 sex-, age-, BMI-, and menopausal status-matched reference individuals. We analyzed bone turnover markers, and measured bone material strength index (BMSi) by impact microindentation. Bone geometry, volumetric density and bone microarchitecture as well as failure load at the distal radius and tibia were evaluated using a second-generation high-resolution peripheral quantitative computed tomography system., Results: Bone turnover markers did not differ between patients with HPP and reference individuals. BMSi did not differ between the groups (67.90 [63.75-76.00] vs 65.45 [58.43-69.55], p = 0.149). Parameters of bone geometry and volumetric density did not differ between adults with HPP and the reference group. Patients with HPP had a tendency toward higher trabecular separation (0.664 [0.613-0.724] mm vs 0.620 [0.578-0.659] mm, p = 0.054) and inhomogeneity of trabecular network (0.253 [0.235-0.283] mm vs 0.229 [0.208-0.252] mm, p = 0.056) as well as lower trabecular bone volume fraction (18.8 [16.4-22.7] % vs 22.8 [20.6-24.7] %, p = 0.054) at the distal radius. In addition, compound heterozygous adults with HPP had a significantly higher cortical porosity at the distal radius than reference individuals (1.5 [0.9-2.2] % vs 0.7 [0.6-0.7] %, p = 0.041)., Conclusions: BMSi is not reduced in adults with HPP. Increased cortical porosity may contribute to the occurrence of femoral pseudofractures in compound heterozygous adults with HPP. However, further studies investigating larger cohorts of adults with HPP using methods of bone histomorphometry are recommended to adequately assess the bone quality in adults with HPP., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Aim: To investigate the efficacy and safety of a non-calorie-restricted low-carbohydrate diet (LCD) on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes (T2D) instructed to maintain their non-insulin antidiabetic medication and physical activity., Materials and Methods: In an open-label randomized controlled trial, patients with T2D were randomized 2:1 to either a LCD with a maximum of 20 E% (percentage of total energy intake) from carbohydrates (n = 49) or a control diet with 50-60 E% from carbohydrates (n = 22) for 6 months. Examinations at enrolment and after 3 and 6 months included blood sample analyses, anthropometrics, blood pressure, accelerometer-based assessment of physical activity, and food diaries. Total fat mass and lean mass were determined by dual-energy x-ray absorptiometry scan. The mean difference in change between groups from baseline are reported., Results: The LCD group decreased carbohydrate intake to 13.4 E% and increased fat intake to 63.2 E%, which was -30.5 ± 2.2 E% lower for carbohydrates and 30.6 ± 2.2 E% higher for fat, respectively, compared with the control group (all P < .001). The LCD reduced HbA1c after 3 months (-8.9 ± 1.7 mmol/mol; P < .0001), and this was maintained after 6 months (-7.5 ± 1.8 mmol/mol; P < .0001) compared with the control diet. The LCD also reduced weight (-3.9 ± 1.0 kg), body mass index (-1.4 ± 0.4 kg/m 2 ), and waist circumference (-4.9 ± 1.3 cm) compared with the control diet (all P < .01), accompanied by reductions in total fat mass (-2.2 ± 1.0 kg; P = .027) and lean mass (-1.3 ± 0.6 kg; P = .017). No changes in blood lipids or blood pressure were seen after 6 months. The level of physical activity was maintained, and there were no episodes of severe hypoglycaemia., Conclusion: A non-calorie-restricted LCD high in fat has significant beneficial effects on glycaemic control and body composition, and does not adversely affect cardiovascular risk factors in patients with T2D. Reducing carbohydrate intake to 10-25 E% appears to be an effective and safe nutritional approach with respect to classical cardiovascular risk factors and hypoglycaemia., (© 2022 John Wiley & Sons Ltd.)

Background: Patients with primary hyperparathyroidism (pHPT) and impaired kidney function (estimated glomerular filtration rate (eGFR) < 60 mL/min) are offered parathyroidectomy (PTX) to protect them from further complications. Surprisingly, two recent uncontrolled cohort studies have suggested a further decrease in kidney function following PTX. We aimed to examine the effects of PTX compared to non-surgical surveillance on kidney function in pHPT patients., Methods: Historic cohort study. From the Danish National Patient Registry (NPR) and major medical biochemistry laboratories in Denmark, we identified 3585 patients with biochemically confirmed pHPT among whom n = 1977 (55%) were treated with PTX (PTX-group) whereas n = 1608 (45%) were followed without surgery (non-PTX group). Baseline was defined as time of diagnosis and kidney function was re-assessed 9-15 months after PTX (PTX group) or 9-15 months after diagnosis (non-PTX group)., Results: At follow-up, eGFR had decreased significantly in the PTX- compared to the non-PTX-group (median - 4% vs. - 1%, p < 0.01). Stratification by baseline eGFR showed that the decrease was significant for those with a baseline eGFR value of 80-89 and > 90 mL/min, but not for those with lower eGFR values. Findings did not differ between patients with mild compared to moderate/severe hypercalcemia. However, after mutual adjustments, we identified baseline levels of calcium, PTH, and eGFR as well as age and treatment (PTX vs. no-PTX) as independent predictors for changes in kidney function., Conclusion: Compared to non-surgical surveillance, PTX is associated with a small but significant decrease in kidney function in pHPT patients with an initial normal kidney function., (© 2022. The Author(s).)

Precise staging of breast cancer-related lymphedema (BCRL) is important to guide treatment-decision making. Recent studies have suggested staging of BCRL using indocyanine green lymphangiography (ICG-L) based on the extent of lymphatic injury and dermal backflow patterns. Currently, the benefits of ICG-L compared to conventional clinical staging are unknown. For this study, we included 200 patients with unilateral BCRL. All BCRL patients were staged using ICG-L and clinical exam. The amounts of excess arm volume, fat mass and lean mass were compared between stages using Dual Energy X-Ray Absorptiometry. Multivariate regression models were used to adjust for confounders. For each increase in the patient's ICG-L stage, the excess arm volume, fat mass and lean mass was increased by 8, 12 and 6.5 percentage points respectively (P < 0.001). For each increase in the patient's clinical ISL stage, the volume was increased by 3.5 percentage points (P < 0.05), however no statistically significant difference in the lean and fat mass content of the arm was observed for ascending stages. However, the residual plots showed a high degree of variance for both ICG-L and clinical staging. This study found that ICG-L staging of BCRL was superior to clinical staging in forecasting BCRL excess arm volume, fat mass, and lean mass. However, there was a high degree of variance in excess arm volume, fat mass, and lean mass within each staging system, and neither the ICG-L nor clinical staging forecasted perfectly., (© 2021. The Author(s).)

Cellulitis is a common complication in Breast Cancer-Related Lymphedema (BCRL). The excess amount of fat and lean mass in BCRL is a vital factor in patient stratification, prognosis, and treatments. However, it is not known whether cellulitis is associated with the excess fat and lean mass in BCRL. Therefore, this prospective observational study was designed to fundamentally understand the heterogonous biocomposition of BCRL. For this study, we consecutively enrolled 206 patients with unilateral BCRL between January 2019 and February 2020. All patients underwent Dual-Energy X-Ray Absorptiometry scans, bioimpedance spectroscopy, indocyanine green lymphangiography comprehensive history of potential risk factors, and a clinical exam. Multivariate linear and beta regression models were used to determine the strength of association and margins effect. Sixty-nine patients (33%) had at least one previous episode of cellulitis. Notably, a previous episode of cellulitis was associated with 20 percentage points more excess fat and 10 percentage points more excess lean mass compared to patients without cellulitis ( p < 0.05). Moreover, each 1 increase in the patients BMI was associated with a 0.03 unit increase in the fat mass proportion of the lymphedema arm. Cellulitis was associated with more excess fat and lean arm mass in BCRL. In addition, patients BMI affect the proportion of fat mass in the arm.

Identifying comorbidities in polymyalgia rheumatica/giant cell arteritis (PMR/GCA) is crucial for patients' outcomes. The present study aimed to evaluate the impact of the inflammatory process and glucocorticoid treatment on aortic arterial stiffness and body composition in PMR/GCA. 77 patients with newly diagnosed PMR/GCA were treated with oral glucocorticoids and followed for 40 weeks. Aortic pulse wave velocity (PWV) was measured at baseline and during the follow-up period and compared to the results of temporal artery biopsy (TAB) and 18F-FDG PET/CT. Body composition was assessed by total body DXA at baseline and the end of the study. Of 77 patients (49 (63.6%) female, mean of age: (71.8 ± 8.0)), 64 (83.1%) had pure PMR, 10 (13.0%) concomitant PMR and GCA, and 3 (3.9%) pure GCA. Compared to baseline values, aortic PWV was initially decreased at week 16 (p = 0.010) and remained lower than baseline at week 28 (p = 0.002) and week 40 (p < 0.001), with no association with results of TAB and 18F-FDG PET/CT. Aortic PWV was significantly associated with age, male gender, left systolic and diastolic blood pressure, right diastolic blood pressure, and CRP. Total bone mineral content (BMC) was decreased in both genders (p < 0.001), while fat mass (FM) was significantly increased (p < 0.001). However, lean body mass did not significantly change during the study. Changes in FM were correlated with cumulative prednisolone dose (rho: 0.26, p = 0.031). Glucocorticoid treatment of patients with PMR/GCA had several prognostic impacts. Arterial stiffness was decreased due either to the treatment or a reduction in the inflammatory load. Additionally, treatment led to changes in body composition, including a decrease in BMC and FM excess.

Objectives: Women diagnosed with asymptomatic osteoporosis need better support to understand the implications of the condition and how to practice self-management in their daily lives. In contrast, physicians report that asymptomatic osteoporosis is not a serious chronic condition and do not pay much attention to the condition compared to other chronic conditions. Therefore, the aim of this study was to investigate the gap between women's needs, when diagnosed with asymptomatic osteoporosis, and what is provided by the healthcare system., Methods: A secondary analysis of semi-structured interviews with 17 women newly diagnosed with asymptomatic osteoporosis was conducted and combined with semi-structured interviews with six physicians. Giorgi's descriptive phenomenological method was used in the analysis., Results: Two overall themes were identified: different perceptions of asymptomatic osteoporosis and discrepancies in the osteoporosis consultation. Habermas was used as a theoretical approach to discuss the findings., Discussion: We discuss that physicians pay too much attention to the objective world and highlight that there is a need for better inclusion of women's subjective and social worlds, to enable mutual understanding and communicative action in the osteoporosis consultation. This would lead to treatment decisions based on women's needs and support women in their self-management of osteoporosis.

Background: Hyperthyroidism is associated with bone mass reduction and increased fracture risk, but the effects on other important bone parameters have been sparsely examined. Therefore, we investigated bone microarchitecture and estimated bone strength by high-resolution peripheral quantitative computed tomography (HR-pQCT) in hyperthyroid patients at diagnosis and after being euthyroid for at least one year. Methods: Two approaches were used: (A) a case-control study comparing 61 hyperthyroid women with 61 euthyroid women matched for age and menopause status; (B) a follow-up study, in which 46 of the 61 women were re-examined after having been euthyroid for one year. HR-pQCT of the distal radius and tibia, and dual-energy X-ray absorptiometry (DXA) of the lumbar spine and the hip were performed. Results: In analysis A: In the radius, compared with the healthy controls, hyperthyroid patients had higher total area (16.9% ± 29.5%; p  < 0.001), trabecular area (28.6% ± 45.7%; p  < 0.001), and lower cortical area (-11.7% ± 23.2%; p  < 0.001). Total volumetric bone mineral density (vBMD) (-13.9% ± 26.5%; p  < 0.001), cortical vBMD (-5.8% ± 7.9%; p  < 0.001), cortical thickness (-16.7% ± 26.0%; p  < 0.001), and estimated bone strength (-6.6% ± 19.5%; p  < 0.01) were lower. No significant differences were found in the tibia or in the DXA parameters. In analysis B: In the radius, significant improvements were observed in the cortical area (2.1% ± 4.6%; p  < 0.01), cortical thickness (2.5% ± 5.1%; p  < 0.001), and total vBMD (0.8% ± 3.0%; p  < 0.05). Trabecular area decreased (-0.5% ± 1.0%; p  < 0.01) and trabecular separation increased (2.0% ± 8.3%; p  < 0.05). In the tibia, cortical area (3.6% ± 7.3%; p  < 0.01) and cortical thickness (3.8% ± 7.6%; p  < 0.01) increased, and trabecular area decreased (-0.5% ± 1.1%; p  < 0.01). Areal BMD, measured by DXA, increased in the spine (1.1% ± 3.4%; p  < 0.05) and in the hip (2.0% ± 3.8%; p  < 0.01). Conclusions: Compared with the healthy control group, hyperthyroid women had lower vBMD, lower estimated bone strength, and compromised cortical microarchitecture in the radius. After restoration of euthyroidism, significant improvements in vBMD and cortical microarchitecture were observed, highlighting the importance of achieving and maintaining euthyroidism.

Purpose: Fracture risk in hypothyroid patients is debated, and since the effects of hypothyroidism on bone microarchitecture and strength are unclarified, we investigated these characteristics by high-resolution peripheral quantitative computed tomography (HR-pQCT)., Methods: Two approaches were used: a cross-sectional control study, comparing 32 hypothyroid women (mean age; 47 ± 12 years) suffering from Hashimoto's thyroiditis with 32 sex-, age-, and menopause-matched healthy controls; a prospective study, where 27 of the women were reexamined 1 year after restoration of euthyroidism. HR-pQCT of the distal radius and tibia, and dual-energy X-ray absorptiometry (DXA) of the spine and hip were performed. Bone strength was estimated using a finite element analysis (FEA)., Results: Cross-sectional control study: in the radius, total (mean 14.6 ± 29.3% (SD); p = 0.04) and trabecular bone areas (19.8 ± 37.1%, p = 0.04) were higher, and cortical volumetric bone mineral density (vBMD) lower (-2.2 ± 6.5%, p = 0.032) in hypothyroid patients than in controls. All indices of tibia cortical and trabecular vBMD, microarchitecture, and estimated bone strength were similar between groups, as was hip and spine areal BMD (aBMD). Prospective study: in the radius, mean cortical (-0.9 ± 1.8%, p = 0.02) and trabecular (-1.5 ± 4.6%, p = 0.02) vBMD decreased, and cortical porosity increased (18.9 ± 32.7%, p = 0.02). In the tibia, mean total vBMD (-1.1 ± 1.9%, p = 0.01) and cortical vBMD (-0.8 ± 1.4%, p = 0.01) decreased, while cortical porosity (8.2 ± 11.5%, p = 0.002) and trabecular area (0.2 ± 0.6%, p = 0.047) increased. No changes in FEA were detected. Lumbar spine aBMD decreased (-1.3 ± 3.0%, p = 0.04)., Conclusions: Hypothyroidism was associated with an increased trabecular bone area and a lower mineral density of cortical bone in the radius, as assessed by HR-pQCT. Restoration of euthyroidism mainly increased cortical porosity, while estimated bone strength was unaffected.

Mammalian carnivores are considered a key group in maintaining ecological health and can indicate potential ecological integrity in landscapes where they occur. Carnivores also hold high conservation value and their habitat requirements can guide management and conservation plans. The order Carnivora has 84 species from 8 families in the Neotropical region: Canidae; Felidae; Mephitidae; Mustelidae; Otariidae; Phocidae; Procyonidae; and Ursidae. Herein, we include published and unpublished data on native terrestrial Neotropical carnivores (Canidae; Felidae; Mephitidae; Mustelidae; Procyonidae; and Ursidae). NEOTROPICAL CARNIVORES is a publicly available data set that includes 99,605 data entries from 35,511 unique georeferenced coordinates. Detection/non-detection and quantitative data were obtained from 1818 to 2018 by researchers, governmental agencies, non-governmental organizations, and private consultants. Data were collected using several methods including camera trapping, museum collections, roadkill, line transect, and opportunistic records. Literature (peer-reviewed and grey literature) from Portuguese, Spanish and English were incorporated in this compilation. Most of the data set consists of detection data entries (n = 79,343; 79.7%) but also includes non-detection data (n = 20,262; 20.3%). Of those, 43.3% also include count data (n = 43,151). The information available in NEOTROPICAL CARNIVORES will contribute to macroecological, ecological, and conservation questions in multiple spatio-temporal perspectives. As carnivores play key roles in trophic interactions, a better understanding of their distribution and habitat requirements are essential to establish conservation management plans and safeguard the future ecological health of Neotropical ecosystems. Our data paper, combined with other large-scale data sets, has great potential to clarify species distribution and related ecological processes within the Neotropics. There are no copyright restrictions and no restriction for using data from this data paper, as long as the data paper is cited as the source of the information used. We also request that users inform us of how they intend to use the data., (© 2020 The Authors. Ecology © 2020 The Ecological Society of America.)

Introduction: Adjuvant treatment of early-stage breast cancer has been associated with bone loss in randomised trials, but evidence from unselected populations is needed. In a single-center study, we assessed the annual percentage change in bone mineral density (∆BMDt) and risk of osteoporosis from two to five years after adjuvant chemotherapy in patients with oestrogen-receptor-positive and oestrogen-receptor-negative tumours., Methods: Dual energy X-ray absorptiometry (DXA) was performed in 241 recurrence-free Danish breast cancer patients, among whom 157 had a prior DXA scan within two years of chemotherapy ("early"). Linear regression was used to assess ∆BMDt in spine and hip according to age, different health-related variables and time since early DXA., Results: Based on 157 patients, we observed annual decreases in spine BMD of 1.73% (95% confidence interval (CI): -2.01--1.44, p less than 0.001) and hip BMD of 1.30% (95% CI: -1.51--1.09, p less than 0.001). Patients aged less than 50 years at diagnosis had a significant decrease in mean spine BMD of 2.23% (95% CI: -2.78--1.68), whereas the decline was more limited in patients aged 50-59 years and patients aged 60 years or older with a mean spine BMD of 1.70% (95% CI: -2.07--1.34) and 0.81% (95% CI: -1.42--0.20), respectively. The results persisted in multivariable analyses. Osteoporosis was diagnosed in 9% of patients, all postmenopausal., Conclusions: Adjuvant anthracycline-taxane-based chemotherapy followed by endocrine therapy caused bone loss, especially in younger compared with older patients with early-stage breast cancer, confirming the results from randomised trials., Funding: This work was supported by the Region of Southern Denmark (grant number 13/7078); the University of Southern Denmark (grant number 00-101-000); the Danish Cancer Society (grant number R90-A6210-14-52); the Department of Oncology and Department of Endocrinology, Odense University Hospital; and the Consultant Council Scholarship, Odense University Hospital., Trial Registration: The study was approved by the Ethics Committee in Region of Southern Denmark (Project ID S-20140142) and the Danish Data Protection Board (ID 2008-58-0035)., (Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.)

Context: The cardiovascular (CV) safety of oral bisphosphonates (oBPs) is uncertain., Objective: Determine the risk of CV events in oBP users referred for bone mineral density (BMD) testing compared with matched controls., Design: Cohort study., Setting: Danish national prescription registry enriched with local hospital data from Odense., Participants: Individuals aged ≥45 years referred for BMD testing., Exposure: oBP., Outcomes: Hospitalization for any CV event. Secondary study outcomes were specific CV events. Negative (inguinal hernia surgery and ingrown toenail) and positive (fragility fracture) control outcomes assessed systemic bias. Cox proportional hazards models were fitted to estimate hazard ratio (HR) and 95% confidence intervals., Results: There were 2565 oBP users (82.6% women) and 4568 (82.3% women) propensity score-matched controls. Alendronate accounted for 96% of oBP prescription. A total of 406 (15.8%) CV events occurred in oBP users (rate = 73.48 [66.67-80.98]); rate = events divided by person-time; and 837 (18.3%) events in controls (rate = 104.73 [97.87-112.07]) with an adjusted HR of 0.68 (95% CI 0.60-0.77). Additional adjustment for BMD did not attenuate estimates (HR 0.67; 95% CI 0.58-0.78]. Similar results were seen for secondary outcomes where risk reductions were seen regarding atrial fibrillation, stroke, heart failure, and aneurysms. Positive and negative control outcome analyses identified minimal residual confounding., Conclusion: Oral BP users experienced a 33% reduced risk of CV events. This observational real-world study adds to a growing body of evidence for cardioprotection by oBP that warrants testing in a randomized setting., (Published by Oxford University Press on behalf of the Endocrine Society 2020.)

Introduction: Patients with type 1 diabetes has an increased risk of fracture. We wished to evaluate estimated bone strength in children and adolescents with type 1 diabetes and assess peripheral bone geometry, volumetric bone mineral density (vBMD) and microarchitecture., Research Design and Methods: In a cross-sectional study, high-resolution peripheral quantitative CT (HR-pQCT) was performed of the radius and tibia in 84 children with type 1 diabetes and 55 healthy sibling controls. Estimated bone strength was assessed using a microfinite element analysis solver. Multivariate regression analyses were performed adjusting for age, sex, height and body mass index., Results: The median age was 13.0 years in the diabetes group vs 11.5 years in healthy sibling controls. The median (range) diabetes duration was 4.2 (0.4-15.9) years; median (range) latest year Hb1Ac was 7.8 (5.9-11.8) % (61.8 (41-106) mmol/mol). In adjusted analyses, patients with type 1 diabetes had reduced estimated bone strength in both radius, β -390.6 (-621.2 to -159.9) N, p=0.001, and tibia, β -891.9 (-1321 to -462.9) N, p<0.001. In the radius and tibia, children with type 1 diabetes had reduced cortical area, trabecular vBMD, trabecular number and trabecular bone volume fraction and increased trabecular inhomogeneity, adjusted p<0.05 for all. Latest year HbA1c was negatively correlated with bone microarchitecture (radius and tibia), trabecular vBMD and estimated bone strength (tibia)., Conclusion: Children with type 1 diabetes had reduced estimated bone strength. This reduced bone strength could partly be explained by reduced trabecular bone mineral density, adverse microarchitecture and reduced cortical area. We also found increasing latest year HbA1c to be associated with several adverse changes in bone parameters. HR-pQCT holds potential to identify early adverse bone changes and to explain the increased fracture risk in young patients with type 1 diabetes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Management of osteoporosis given reduced renal function is one of the largest challenges in the bone clinic., Objectives: Identify the cut-off for renal function below which there would be no overall BMD benefit associated with bisphosphonate use. Track safety outcomes resulting in hospital encounters., Methods: Population-based, observational register-linked study of BMD trajectories in adults from the island of Funen (pop 465,000) as a function of estimated creatinine clearance (CKD-epi), treatment and adherence to oBP. One laboratory performed all the biochemical analyses for the area while all DXA scans were in a central facility. For inclusion, patients were required to have both a DXA scan and an eGFR measurement (CKD-EPI) within 1 year prior to their study index date. Medication Possession Ratio (MPR) was calculated from national data., Results: Out of 6176 incident BP users, 1789 had eGFR and DXA measurements at appropriate timepoints for the planned analysis, while this was the case for 3908 of 29,336 non-users. Users of oBPs exhibited progressively smaller gains in BMD with decreasing renal function. However, for CKD stage 3A and better, the annual change in BMD was significantly more positive than in the non-user group at similar levels of renal function. In non-users, the average annual change in BMD was negative but largely unaffected by renal function down to stage 3B. There were no new cases of acute renal injury, glomerulonephritis or dialysis. The rate of new kidney transplantation was zero in non-users and 0.26 per 1000 PY in the BP user population. Hypocalcaemia encounters did not differ significantly from that seen in non-users., Conclusions: The BMD changes observed in real-world users of oBP in this population based single-clinic are consistent with those observed in the original RCTs of alendronate. We noted a gradual decrease in the absolute gains in BMD in oBP users with decreasing renal function though there was no significant interaction - largely explained by low numbers of treated patients with poor renal function - between CKD stage and adherence driven BMD change. There were no cases of acute renal injury resulting in hospital encounters. More data is needed on the efficacy and safety of bisphosphonates in CKD stage 3B to 5 and prescribers should reconsider the low use of DXA in patients with renal function impairment now that a wider range of treatment options are available., Competing Interests: Declaration of competing interest BA: Consulting and speakers fees Amgen, UCB, Kyowa-Kirin UK. Institutional research contracts UCB and Novartis. DPA: Grants and other support from AMGEN, grants, non-financial support and other from UCB Biopharma, grants from Laboratoires Servier, outside the submitted work; and Janssen, on behalf of IMI-funded EHDEN and EMIF consortiums, and Synapse Management Partners have supported training programmes organised by DPA's department and open for external participants. APH: Consulting and speakers fees Amgen, UCB. Institutional research contracts Kyowa-Kirin UK and Shire. CDS, MTE, MN, KHR: None., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: Malnutrition and low weight in eating disorders (EDs) are associated with increased fracture risk compared to the general population. In a cohort study, we aimed to determine fracture rates compared to age and gender matched controls (ratio 5:1), assess the impact of disease remission on fracture risk, and establish predictive factors for fractures., Method: Of note, 803 ED patients referred to specialized ED treatment between 1994 and 2004 were included. In 2016, data on fractures were obtained through the Danish National Registry of Patients., Results: Fracture risk was increased in anorexia nervosa (AN; IRR 2.2 [CI 99%: 1.6-3.0]) but not in bulimia nervosa (BN; IRR 1.3, ns) or other specified feeding or eating disorders (OSFED; IRR 1.8, ns). IRR in the AN group were increased for vertebral fractures (IRR 3.8 [CI 99%: 1.4-10.3]), upper arm (IRR 3.0 (CI 99% 1.6-5.5) and hip (IRR 6.6 [CI 99%: 2.6-18.0]). Disease remission in AN is associated to lower fracture risk compared to active disease, but higher fracture risk compared to controls (IRR 1.7 [CI 99%: 1.1-2.7]). In regression analysis, age at debut of disease, nadir BMI and duration of disease before referral to treatment, independently predicted fracture., Discussion: We confirm increased fracture risk in AN, and show significant differences in fracture risk between patients in disease remission and patients with active disease. Furthermore, we show that age at debut of disease and duration of disease before referral to treatment is positively correlated to fracture risk, whereas nadir BMI is negatively correlated to fracture risk., (© 2020 Wiley Periodicals, Inc.)

Objective: To suggest recommendations for the practice of Home Nursing in the context of COVID-19., Method: Reflective study, originated from readings associated with the theme, available in current guidelines from the Pan American Health Organization, World Health Organization and the Ministry of Health., Results: Recommendations were developed from current scientific evidence for prevention of infections, control of epidemics and pandemics in the Brazilian home scenario., Final Considerations: the reflections achieved contribute to guiding actions for better assistance to the patient, family caregivers and the community in the perspective of safe home care with COVID-19, and it is characterized as an introductory discussion on the theme, encouraging new studies to be carried out from the unfolding of the current scenario.

Bisphosphonates are contraindicated in moderate-to-severe chronic kidney disease patients. However, they are used to prevent fragility fractures in patients with impaired kidney function, despite a lack of evidence on their effects on bone density in these patients. We demonstrated that Alendronate had a positive effect on bone in these patients., Purpose: This study aimed to assess the association between alendronate use and bone mineral density (BMD) change in subjects with moderate-severe chronic kidney disease (CKD)., Methods: We created a cohort of CKD stage 3B-5 patients by linking all DXA-based measurements in the Funen area, Denmark, to biochemistry, national health registries and filled prescriptions. Exposure was dispensation of alendronate and the outcome was annualized percentage change in BMD at the femoral neck, total hip and lumbar spine. Individuals were followed from first BMD to the latest of subsequent DXA measurements. Alendronate non-users were identified using incidence density sampling and matched groups were created using propensity scores. Linear regression was used to estimate average differences in the annualized BMD., Results: Use of alendronate was rare in this group of patients: propensity score matching (PSM) resulted in 71 alendronate users and 142 non-users with stage 3B-5 CKD (as in the 1 year before DXA). Whilst alendronate users gained an average 1.07% femoral neck BMD per year, non-users lost an average of 1.59% per annum. The PSM mean differences in annualized BMD were + 2.65% (1.32%, 3.99%), + 3.01% (1.74%, 4.28%) and + 2.12% (0.98%, 3.25%) at the femoral neck, total hip and spine BMD, respectively, all in favour of alendronate users., Conclusion: In a real-world cohort of women with stage 3B-5 CKD, use of alendronate appears associated with a significant improvement of 2-3% per year in the femoral neck, total hip and spine BMD. More data are needed on the anti-fracture effectiveness and safety of bisphosphonate therapy in moderate-severe CKD.

Objective: Eating disorders (EDs) are associated with decreased bone mineral density (BMD) and increased fracture risk. The association between BMD and fracture risk in EDs is not well elucidated. We aimed to assess BMD in an ED cohort of patients with active disease and patients in remission, and to assess the predictive value of BMD on incidence of fractures., Method: We included 344 female patients (median age 19, IQR 16; 24) referred to ED treatment. Later, patients were invited to follow-up including assessment of remission status and a dual-energy x-ray absorptiometry (DXA)-scan. Information on fractures was obtained through the Danish National Registry of Patients., Results: Patients with current anorexia nervosa (AN) had significantly lower BMD compared to controls at lumbar spine (16% lower, p < .0001), femoral neck (18% lower, p < .0001), and total hip (23% lower, p < .0001). Recovered AN patients had higher BMD compared to those with current disease (p < .0001 for all measures), but lower BMD compared to controls at lumbar spine (p < .01) and hip (p < .001). BMD did not differ between BN patients and controls. In patients with active eating disorders not otherwise specified, BMD was lower only at the total hip (p < .005). We found no association between BMD and fracture risk., Conclusion: We confirm that AN is associated with low BMD, whereas BN is not. Remission is associated with higher BMD compared to patients with active AN, but a deficit remains. We found no significant association between BMD and fracture risk, challenging the benefit of the widespread use of DXA scans in young women with ED., Clinical Trial Registration: The study is registered in ClinicalTrials.gov, number NCT00267228., (© 2020 Wiley Periodicals, Inc.)

Objective: Roux-en-Y-gastric bypass (RYGB) surgery is an effective treatment for morbid obesity. A possible overlooked side effect is negative bone metabolic consequences., Design: A seven-year prospective study following ten women and seven men after RYGB (baseline mean age 43 ± 8 years, BMI 42 ± 6 kg/m2)., Methods: Lumbar spine and total hip bone mineral density (BMD) using dual energy x-ray absorptiometry, distal radius and tibia bone geometry, volumetric BMD, microarchitecture and finite element estimated bone strength using high-resolution peripheral quantitative CT and biochemical markers of bone remodelling were assessed at baseline, 2 and 7 years., Results: Compared to baseline, body weight was 24 ± 10% lower after 2 years and 21 ± 11% after 7 years. During the 7 years of follow-up, radius and tibia vBMD had declined 13 ± 8% and 8 ± 7% from baseline to 2 years and further 10 ± 7% and 7 ± 8% from 2 to 7 years (all P < 0.001). At both radius and tibia, cortical thickness declined and cortical porosity increased. From baseline to 7 years, there were clear indications of deteriorations of the trabecular network with fewer, more widely spaced and more in-homogeneously distributed trabeculae in both radius and tibia. Overall, declines in estimated bone strength of 16 ± 9% in radius and 16 ± 7% in tibia were observed (both P < 0.001)., Conclusion: Seven years after RYGB, evidence of continuous declines in BMD and ongoing deterioration of bone microarchitecture and reduced estimated bone strength compared to baseline and 2 years post-surgery results were found. These findings emphasize the need for regular assessment of bone health in patients with prior RYGB.

Objective: to identify, based on the evidence, point-of-care testing in bedbound in critically ill patients., Method: integrative review, carried out through search in Pubmed, Virtual Health Library, Joanna Briggs Institute, The British Institute of Radiology, Brazilian Radiology, and Google Scholar databases. We used the PICO research strategy and selected articles published from 2013 onwards, which presented information about point-of-care testing., Results: the different interventions found in the analysis of the 23 selected articles allowed the thematic grouping of care related to safety in communication, patient identification, care with devices, and the prevention and control of infection, which can be used in point-of-care testing. Final considerations: The care described in the evidence provided support for validating a safe care protocol for critically ill patients undergoing imaging studies in bed.

Use of antiosteoporotic medication in the population-based, risk-stratified osteoporosis strategy evaluation (ROSE) screening study, comparing the use of FRAX followed by DXA with usual care, was examined. Screening increased the overall use of medication. Being recommended treatment by the hospital and higher age increased the likelihood of starting medication, but, nevertheless, a large percentage opted not to start treatment., Introduction: The aim of the study was to examine the impact on medication prescription, adherence, and persistence of osteoporotic medicine in the randomized population-based ROSE screening study for osteoporosis., Methods: The Danish ROSE study included a population-based random sample of women aged 65-81 years randomized to either a two-step screening program consisting of FRAX followed by DXA for high-risk participants or opportunistic screening for osteoporosis (usual care). This sub-study on the intention-to-treat population examined the impact of the screening program on antiosteoporotic medication redemption rates, adherence, and persistence using Danish registers., Results: A total of 30,719 of 34,229 women were treatment-naïve. Significantly more participants in the screening group started on antiosteoporotic medication, but no differences in adherence and persistence rates were found. Higher age was associated with a higher likelihood of starting medication. A low Charlson comorbidity score (= 1) was associated with higher treatment initiation but lower adherence and persistence of antiosteoporotic treatment. A total of 31.7% of participants advised to initiate treatment did not follow the advice., Conclusions: Screening for osteoporosis using FRAX followed by DXA increased the overall use of antiosteoporotic medication in the screening group without differences in adherence and persistence rates. A large percentage of participants advised to initiate treatment did nevertheless fail to do so.

Objective: to know the care provided by family caregivers of children submitted to hematopoietic stem cell transplantation., Method: the Grounded Theory was used as methodology. The study comprised four sample groups, comprising 36 caregivers. Data were collected by semi-structured interviews and analyzed according to the coding proposed by Strauss and Corbin in three phases: open, axial and selective., Results: eight propositions were identified for the care provided to the child in the researched context, namely administering medications; attention to cleaning issues; care with water and food intake; care with the body; experiencing protective isolation; addressing the child's need for emotional support; addressing the child's self-care; and facing complications., Conclusion: the different aspects in which the caregiver acts in the care of the child were understood. Such care equips the health team to elaborate measures for guidance and preparation of home care that are effective and directed to the needs of the patient and their family. The understanding of the care that they accomplish enables the caregiver a greater understanding of their role, as well as of the decisions they will make by their being under treatment.

Objectives: This study aims to test a mobile health application (mHealth app) developed to meet the needs of women newly diagnosed with asymptomatic osteoporosis. We investigate how the women experience using an mHealth app upon diagnosis of osteoporosis and whether the app can help them to be prepared for treatment decision-making and support them in osteoporosis self-management. We also tested the usability of the app, to find out whether any adjustments were necessary prior to implementation., Methods: A test was conducted at a Danish university hospital with 18 women aged 50-65, newly diagnosed with asymptomatic osteoporosis. On presenting for a bone density scan at the hospital, they were provided with the app, which was named 'My Osteoporosis Journey'. Data were collected through semi-structured interviews. Giorgi's descriptive phenomenological method guided the data analysis in four steps., Findings: In total, 17 women succeeded in downloading the app, thereby accessing information on asymptomatic osteoporosis, their bone density scan results and treatment recommendations prior to visiting their general practitioner. Three overall themes were identified. Women experienced that the app (1) gave a feeling of confidence and reassurance, (2) prepared the women on treatment decision-making in the general practitioner visit and (3) provided help at hand in self-management of osteoporosis., Conclusion: Our findings show that the mHealth app helps women to feel confident and reassured upon diagnosis of asymptomatic osteoporosis. The women felt that the app promoted an equal dialogue in the osteoporosis consultation since they felt prepared for visiting their general practitioner and were able to articulate their individual needs regarding treatment. After diagnosis, the women felt that the app provided support in self-management, right at their fingertips., Competing Interests: Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Patients with chronic obstructive pulmonary disease (COPD) are at risk of developing osteoporosis, as the COPD in itself as well as continued smoking and treatment with systemic corticosteroid all increase the risk of developing osteoporosis. Other risk factors for osteoporosis are low vitamin D levels, malnutrition and physical inactivity. All patients who have risk factors in the form of severe COPD, and all patients with COPD in active treatment with systemic corticosteroid and/or other risk factors should be examined with a DEXA-scan. Treatment of osteoporosis in patients with COPD does not differ from general recommendations.

This systematic review provides synthesised knowledge and guidance to health professionals on the experiences and perspectives of being diagnosed with osteoporosis from the patient's point of view. Using individuals' experiences and meanings can promote tailored and targeted information and guidance on osteoporosis, bone care and treatment at different stages of the osteoporosis trajectory., Introduction: To be diagnosed with osteoporosis with or without fragility fractures affects individuals differently. The aim of this review was firstly to aggregate existing qualitative evidence regarding an individual's experience of being diagnosed with osteoporosis at different stages, and secondly, to use a systematic approach to develop a conceptual understanding of central issues relevant for health professionals in order to provide support and guidance to patients/individuals., Methods: This study used a systematic review methodology and methods for qualitative synthesis as recommended by Cochrane and integrated the findings of qualitative research from eight databases (Medline, PubMed, CINAHL, Embase, SweMed+, PsycINFO, ERIC, Web of Science) to July 2016. Selection and assessment were performed by three authors while four authors were involved in the analysis. Findings were cross-checked with the original article to ensure consistency with the individual's accounts., Results: Our findings have revealed that individuals diagnosed with osteoporosis do not perceive osteoporosis as a biomedical trajectory but as a self-perceived continuum of severity and health. To be diagnosed with osteoporosis affects individuals differently depending on, for example, personal experience, pre-conceived notions of or knowledge about the disease, fragility fractures or pain. Hence, individuals will create a meaning of the diagnosis based on self-perceived fracture risk, self-perceived severity of osteoporosis and at the same time, self-perceived health., Conclusions: This meta-synthesis provides knowledge for health professionals on the experiences and perspectives of being diagnosed with osteoporosis from the patient's point of view. The experience, meaning and significance of osteoporosis must be taken into consideration and can be used to promote tailored and targeted information and guidance on osteoporosis, bone care and treatment at different stages of the osteoporosis trajectory.

The Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study investigated the effectiveness of a two-step screening program for osteoporosis in women. We found no overall reduction in fractures from systematic screening compared to the current case-finding strategy. The group of moderate- to high-risk women, who accepted the invitation to DXA, seemed to benefit from the program., Introduction: The purpose of the ROSE study was to investigate the effectiveness of a two-step population-based osteoporosis screening program using the Fracture Risk Assessment Tool (FRAX) derived from a self-administered questionnaire to select women for DXA scan. After the scanning, standard osteoporosis management according to Danish national guidelines was followed., Methods: Participants were randomized to either screening or control group, and randomization was stratified according to age and area of residence. Inclusion took place from February 2010 to November 2011. Participants received a self-administered questionnaire, and women in the screening group with a FRAX score ≥ 15% (major osteoporotic fractures) were invited to a DXA scan. Primary outcome was incident clinical fractures. Intention-to-treat analysis and two per-protocol analyses were performed., Results: A total of 3416 fractures were observed during a median follow-up of 5 years. No significant differences were found in the intention-to-treat analyses with 34,229 women included aged 65-80 years. The per-protocol analyses showed a risk reduction in the group that underwent DXA scanning compared to women in the control group with a FRAX ≥ 15%, in regard to major osteoporotic fractures, hip fractures, and all fractures. The risk reduction was most pronounced for hip fractures (adjusted SHR 0.741, p = 0.007)., Conclusions: Compared to an office-based case-finding strategy, the two-step systematic screening strategy had no overall effect on fracture incidence. The two-step strategy seemed, however, to be beneficial in the group of women who were identified by FRAX as moderate- or high-risk patients and complied with DXA.

Introduction Despite the fact that the first osteoporotic fracture is preventable, osteoporosis is still a major health challenge. The disease is highly prevalent among postmenopausal women. However little is known about how to meet and support women, when they are diagnosed with osteoporosis without preceding fractures. Therefore this study aims at gaining a deeper understanding of how women experience being diagnosed. Furthermore to describe and identify their needs, which should be met in future healthcare services. Methods We conducted a phenomenological qualitative study. We included 17 women aged 52-65 and collected data through semi-structured interviews. We analysed data following Giorgi's methodology. Findings Needs among the women were classified into three main themes: (1) needs of targeted and tailored information about osteoporosis, (2) needs of being prepared for GP visit to participate in treatment decision-making and (3) needs of being able to take care of bone health. Conclusion and implications In general the women experienced as been left 'in limbo', and they requested targeted and tailored information about osteoporosis. In particular, they want information about dual-energy X-ray absorptiometry (DXA) scan results and treatment options in advance of the GP visit. This will help them in being prepared and able to participate in treatment decisions. They ask for support in self-management of the disease with less focus on disease and risk of fracture. Instead, they demand more attention on the benefits of detecting early stage osteoporosis. The study highlights the call for new approaches to postmenopausal women newly diagnosed with osteoporosis without preceding fractures.

mHealth is a useful tool to improve health outcome within chronic disease management. However, mHealth is not implemented in the field of postmenopausal osteoporosis even though it is a major worldwide health challenge. Therefore, this study aims to design and develop an mHealth app to support women in self-management of osteoporosis when they are diagnosed without preceding fractures. Participatory design is conducted in three phases. Based on identified needs in the first phase, a prototype is designed and developed in an iterative process in the second phase before the mHealth app is tested in the third phase. This paper focuses on the user activities in phase two and describes how a team of researchers, women, physicians, healthcare professionals, and app designers are involved in the participatory design process. The study shows that participatory design is a viable approach when developing an mHealth app for women with asymptomatic osteoporosis. Results obtained from the workshops and laboratory tests demonstrate the importance of feedback from users in the iterative process, as well as the participation of users and app designers in workshops and laboratory tests to enable mutual learning when developing new mHealth solutions. The regular member-checks and involvement of users helped to identify challenges associated with providing healthcare services through an app., Competing Interests: The authors declare no conflict of interest.

Background: Patients with systemic mastocytosis (SM) may suffer from mast cell (MC) mediator-related symptoms insufficiently controlled by conventional therapy. Omalizumab is an established treatment in other MC-driven diseases, but experiences in SM are limited., Objective: To assess the efficacy and safety of omalizumab in SM., Methods: In our patient cohort, we evaluated all SM patients treated with omalizumab. A physician global assessment of type and severity of symptoms was performed at baseline, at 3 and 6 months and at latest follow-up. Quality of life was assessed by visual analogue scale. S-tryptase and KIT D816V allele burden were monitored., Results: A total of 14 adult SM patients (10 ISM, 2 BMM, 1 SSM, and 1 ASM-AHN) received omalizumab with a median duration of 17 months (range: 1-73 months). One patient was excluded due to concomitant cytoreductive therapy. In the remaining 13 patients, we observed a significant reduction in symptoms, with complete symptom control in five (38.5%), major response in three (23.1%), and a partial response in three (23.1%) patients, whereas two patients (15.4%) withdrew due to subjective side-effects at first dose. The treatment was most effective for recurrent anaphylaxis and skin symptoms, less for gastrointestinal, musculoskeletal, and neuropsychiatric symptoms. Patient-reported quality of life showed significant improvement. No significant changes in s-tryptase/KIT D816V allele burden were observed. No severe adverse events were recorded., Conclusions: Omalizumab appears to be a promising treatment option in SM, effectively preventing anaphylaxis and improving chronic MC mediator-related symptoms, insufficiently controlled by conventional therapy. Controlled studies are needed to substantiate findings., (© 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.)

Objective: to identify possibilities for improvement in the process of teaching and learning homecare in nursing, pharmacy, medicine, nutrition, dentistry and occupational therapy courses., Method: qualitative research using the Grounded Theory approach. Sixty-three semi-structured interviews were conducted with students, teachers and graduates of the six mentioned courses at a public university in the south of Brazil. Data analysis was performed through open, axial and selective coding., Results: the possibilities for improving the process of teaching and learning homecare included: scientific production in the area; use of different teaching techniques; development of extracurricular activities; extension projects; curricular reformulation; and laboratory simulation., Final Considerations: the strategies cited in this study enable undergraduate courses in health to envisage the possibility of enhance the process of teaching and learning homecare.

Population-based screening for osteoporosis is still controversial and has not been implemented. Non-participation in systematic screening was evaluated in 34,229 women age 65-81 years. Although participation rate was high, non-participation was associated with comorbidity, aging other risk factors for fractures, and markers of low social status, e.g., low income, pension, and living alone. A range of strategies is needed to increase participation, including development of targeted information and further research to better understand the barriers and enablers in screening for osteoporosis., Introduction: Participation is crucial to the success of a screening program. The objective of this study was to analyze non-participation in Risk-stratified Osteoporosis Strategy Evaluation, a two-step population-based screening program for osteoporosis., Methods: Thirty-four thousand two hundred twenty-nine women aged 65 to 81 years were randomly selected from the background population and randomized to either a screening group (intervention) or a control group. All women received a self-administered questionnaire designed to allow calculation of future risk of fracture based on FRAX. In the intervention group, women with an estimated high risk of future fracture were invited to DXA scanning. Information on individual socioeconomic status and comorbidity was obtained from national registers., Results: A completed questionnaire was returned by 20,905 (61%) women. Non-completion was associated with older age, living alone, lower education, lower income, and higher comorbidity. In the intervention group, ticking "not interested in DXA" in the questionnaire was associated with older age, living alone, and low self-perceived fracture risk. Women with previous fracture or history of parental hip fracture were more likely to accept screening by DXA. Dropping out when offered DXA, was associated with older age, current smoking, higher alcohol consumption, and physical impairment., Conclusions: Barriers to population-based screening for osteoporosis appear to be both psychosocial and physical in nature. Women who decline are older, have lower self-perceived fracture risk, and more often live alone compared to women who accept the program. Dropping out after primary acceptance is associated not only with aging and physical impairment but also with current smoking and alcohol consumption. Measures to increase program participation could include targeted information and reducing physical barriers for attending screening procedures.