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O presente artigo se coloca em uma atenção para as narrativas possíveis sobre aborto, a partir da perspectiva das crianças. Meninas obrigadas a gestar e parir. Violentadas por adultos. Aborto legal negado a elas. Mas também, crianças que irrompem criando rupturas nos essencialismos nos quais se sustenta o sistema binário e heterocisnormativo. Crianças que se resistem à infância que a modernidade produziu para elas. Crianças que problematizam as modalidades de tutela adulta que essa modernidade construiu. Crianças que se posicionam e interpelam a naturalização das maternidades forçadas e se colocam para abortar as infâncias produzidas para estas a partir de temáticas como autonomia corporal e práticas abortivas. Enquanto categoria analítica, afirmamos a criança que vai além das bordas estabelecidas para falar sobre aborto e, se pergunta sobre a possibilidade de pensá-la para além do corpo que gesta, profanando o aborto e o dizer sobre este para ela.

The topical administration of a drug compound remains the first choice for the treatment of many local skin ailments. Many skin diseases can be treated by applying the active formulation directly to the skin, but unfortunately some drugs are unable to overcome the stratum corneum and exert their pharmacological action. An example is thymoquinone, a naturally derived drug obtained from Nigella sativa L. and potentially effective in the treatment of inflammatory and oxidative skin conditions. Since its physico-chemical properties are not suitable for overcoming the stratum corneum, we wanted to circumvent the problem by proposing new lipid-based nanovesicles called "oleoethosomes", made up of naturally derived ingredients, for its delivery. Among several formulations of oleoethosomes, the sample made up of 2% (w/w) oleic acid:PL90G 1:1 (molar ratio), and ethanol 15% showed the best physico-chemical characteristics and above all it showed the capacity to contain a suitable amount of thymoquinone (2 mg/ml). The formulation was tested in vitro on stratum corneum and viable epidermis membranes confirming its ability to induce the passage of thymoquinone through the human stratum corneum and to act as a permeation enhancer. In fact, it showed thymoquinone permeation values of 22.63 ± 1.49% regarding the applied drug amount. Oleoethosomes were compared with oleosomes, another kind of naturally derived nanosystems but free of ethanol. The experimental data confirmed that ethanol was an important component that enhanced the activity of the oleoethosomes when tested on the skin of healthy volunteers. The thymoquinone-loaded oleoethosome treatment demonstrated a significantly greater extent of anti-inflammatory activity than the treatment with thymoquinone-loaded oleosomes or the conventional dosage form of the drug. These in vivo results confirmed the synergic effect between oleic acid and ethanol on the lipid and protein compartments of the outermost skin layer, thus promoting a greater penetration capacity.

Labrafil M2125-CS is a non-ionic surfactant component widely used for improving the solubilization of poor water-soluble drugs and as component of lipid-based nanosystem formulation. The aim of this research work was to evaluate in depth the stability of lipid-based nanosystems when exposed at several experimental conditions, such as temperature- and pH-variations, and during a specific storage process—lyophilization. Dynamic light scattering was the main analysis carried out during this research work for investigating eventual physico-chemical variations of nanosystem properties after different storage phases. We demonstrated that many of prepared formulations were able to maintain almost unchanged mean size and polydispersity index values, resisting acid and basic pH or high and low temperature, as well as the freeze-drying process. Finally, the results showed that there are no univocal experimental conditions suitable for the storage of all formulation types, but each sample requires customized conditions.

Summary In this longitudinal study, with a follow-up of 8 years, multidimensional prognostic index (MPI), a product of the comprehensive geriatric assessment, significantly predicted the onset of fractures in older people affected by knee osteoarthritis. Purpose Frailty may be associated with higher fracture risk, but limited research has been carried out using a multidimensional approach to frailty assessment and diagnosis. The present research aimed to investigate whether the MPI, based on comprehensive geriatric assessment (CGA), is associated with the risk of fractures in the Osteoarthritis Initiative (OAI) study. Methods Community-dwellers affected by knee OA or at high risk for this condition were followed-up for 8 years. A standardized CGA including information on functional, nutritional, mood, comorbidity, medication, quality of life, and co-habitation status was used to calculate the MPI. Fractures were diagnosed using self-reported information. Cox’s regression analysis was carried out and results are reported as hazard ratios (HRs), with their 95% confidence intervals (CIs), adjusted for potential confounders. Results The sample consisted of 4024 individuals (mean age 61.0 years, females = 59.0%). People with incident fractures had a significant higher MPI baseline value than those without (0.42 ± 0.18 vs. 0.40 ± 0.17). After adjusting for several potential confounders, people with an MPI over 0.66 (HR = 1.49; 95%CI: 1.11–2.00) experienced a higher risk of fractures. An increase in 0.10 point in MPI score corresponded to an increase in fracture risk of 4% (HR = 1.04; 95%CI: 1.008–1.07). Higher MPI values were also associated with a higher risk of non-vertebral clinical fractures. Conclusion Higher MPI values at baseline were associated with an increased risk of fractures, reinforcing the importance of CGA in predicting fractures in older people affected by knee OA.

Pre-operative delirium may cause delay in surgical intervention in older patients hospitalized for hip fracture. Also it has been associated with higher risk of post-surgical complications and worst functional outcomes. Aim of this retrospective cohort study was to evaluate whether the multidimensional prognostic index (MPI) at hospital admission was associated with pre-operative delirium in older individuals with hip fracture who are deemed to require surgical intervention. Consecutive older patients (≥ 65 years) with hip fracture underwent a comprehensive geriatric assessment to calculate the MPI at hospital admission. According to previously established cut-offs, MPI was expressed in three grades, i.e. MPI-1 (low-risk), MPI-2 (moderate-risk) and MPI-3 (high risk of mortality). Pre-operative delirium was assessed using the four ‘A’s Test. Out of 244 older patients who underwent surgery for hip fracture, 104 subjects (43%) received a diagnosis of delirium. Overall, the incidence of delirium before surgery was significantly higher in patients with more severe MPI score at admission. Higher MPI grade (MPI-3) was independently associated with higher risk of pre-operative delirium (OR 2.45, CI 1.21–4.96). Therefore, the MPI at hospital admission might help in early identification of older patients with hip fracture at risk for pre-operative delirium.

Neste artigo propomos problematizar o dispositivo da maternidade, bem como algumas normativas maquinadas para tentar definir uma categoria nomeada "mulher", a partir de nossas pesquisas com os corpos que gestam e as maternidades, bem como dos textos publicados no livro Sangrias (2019). Tratamos a maternidade enquanto dispositivo biopolítico, tecnologia que busca produzir e manter certos modos de vida em coerência com forjada lógica sexo-gênero, bem como a heterossexualidade compulsória, que serve a uma determinada sociedade capitalista neoliberal. Diante a esse cenário, apostamos em epistemologias transbordantes feministas de vida e de pesquisa que nos convocam a uma fluidez e transposição das fronteiras das categorias identitárias como forma de produzir escapes e outras configurações sobre gestações e maternagens, outras formas de vida. Apostamos na política ciborgue, proposta por Donna Haraway como tática de produção de outros e transitórios corpos, moventes e constituídos pautados no desejo ético, nos prazeres e na alegria como tática potente de (re)existir.

This work aims at (1) assessing the potential of repurposing simvastatin (SV) to support the most common therapies against melanoma and (2) developing an innovative topical adhesive film, composed by chitosan-coated nanostructured lipid carriers (Ch-NLC) used as drug vehicle. A factorial design approach was employed as the basis for the formulation development. Optimized Ch-NLC displayed a particle size of 108 ± 1 nm, a polydispersity index of 0.226, a zeta potential of 17.0 ± 0.6 mV, as well as an entrapment efficiency of 99.86 ± 0.08%, and SV loading of 14.99 ± 0.01%. The performance of SV-Ch-NLC films was assessed in terms of release, permeation, and adhesion, as critical quality attributes. Cutaneous tolerability and in vitro cytotoxicity studies were performed to warrant film safety and drug effectiveness, respectively. The topical films provided a sustained release kinetic profile of SV and were classified as nonirritant systems. The encapsulation of SV increased cytotoxicity in melanoma cells. The key role of squalene as nanostructuring agent of the lipid nanoparticle matrix and as permeation enhancer was highlighted, suggesting its key action for potentiating skin permeation and uptake into melanoma cells. Topical SV-Ch-NLC films are thus able to provide an in situ extended drug delivery and useful as coadjuvant treatment of melanoma skin lesions.

A novel effervescent buffered solution of 70 mg alendronate (ALN-EX) was developed to improve upper gastrointestinal (GI) tolerability over alendronate tablets (ALN-T). Whether a better GI tolerability can improve persistence remains to be determined. This study evaluated persistence and reasons for discontinuation in patients treated with ALN-EX compared to a historical cohort on ALN-T. Post-menopausal women (PMW) from a standardized clinical database with BMD T-score

Cardiac remuscularization has been the stated goal of the field of regenerative cardiology since its inception. Along with the refreshment of lost and dysfunctional cardiac muscle cells, the field of cell therapy has expanded in scope encompassing also the potential of the injected cells as cardioprotective and cardio-reparative agents for cardiovascular diseases. The latter has been the result of the findings that cell therapies so far tested in clinical trials exert their beneficial effects through paracrine mechanisms acting on the endogenous myocardial reparative/regenerative potential. The endogenous regenerative potential of the adult heart is still highly debated. While it has been widely accepted that adult cardiomyocytes (CMs) are renewed throughout life either in response to wear and tear and after injury, the rate and origin of this phenomenon are yet to be clarified. The adult heart harbors resident cardiac/stem progenitor cells (CSCs/CPCs), whose discovery and characterization were initially sufficient to explain CM renewal in response to physiological and pathological stresses, when also considering that adult CMs are terminally differentiated cells. The role of CSCs in CM formation in the adult heart has been however questioned by some recent genetic fate map studies, which have been proved to have serious limitations. Nevertheless, uncontested evidence shows that clonal CSCs are effective transplantable regenerative agents either for their direct myogenic differentiation and for their paracrine effects in the allogeneic setting. In particular, the paracrine potential of CSCs has been the focus of the recent investigation, whereby CSC-derived exosomes appear to harbor relevant regenerative and reparative signals underlying the beneficial effects of CSC transplantation. This review focuses on recent advances in our knowledge about the biological role of exosomes in heart tissue homeostasis and repair with the idea to use them as tools for new therapeutic biotechnologies for “cell-less” effective cardiac regeneration approaches.

Background: Hip fractures (HF) are a major issue worldwide. We aimed at evaluating the practices in delivering care to patients with HF among several Italian Orthogeriatric centers. Methods: The study took place from February 2016 to July 2018. Seven performance indicators (pre-surgical cognitive assessment, surgery performed ≤ 48h from fracture, removal of urinary catheter/absence of delirium/start of physiotherapy on the first post-operative day, prescription of bone protection at discharge, and discharge toward rehabilitation) were collected. Results: The 14 participating hospitals totally recruited 3.017 patients. Patients were old (median age 86years; Inter Quartile Range [IQR] 80–90), mostly females (77%). Nearly 55% of them were already impaired in mobility and about 10% were nursing home residents. Median time-to-surgery was 41h (IQR 23–62). Models of care greatly varied among centers, only 49.3% of patients being co-managed by geriatricians and orthopedics. There was high variability across centers in four indicators (“pre-surgical cognitive assessment”, “bone protection prescription”, “use of urinary catheter” and “start of physiotherapy”), moderate in two indicators (“surgery performed ≤ 48h from fracture” and “discharge toward rehabilitation” and low in one (“absence of delirium on day following surgery”). Comparison with international studies suggests very different ways of providing care to HF Italian patients. Conclusions: The study results suggest high inter-center variability in the key-performance indicators, and different approaches in providing care to our HF patients in comparison to other countries. A National debate on the topic is required in Italy to harmonize practices of orthogeriatric care.

This systematic review on sexualities and gender covers 80 articles, published by the Interamerican Journal of Psychology until the year 2019. The sample, selected and classified into three themes by the thematic analysis method, shows a productivity raise in this regard upon the 1990s. Ever since, debates on sexual differences and roles amidst the sample have declined while productions on gender have grown, according to the first theme. On the second, it was possible to infer that such an increase had significant collaboration from the health areas, highlighting yet the importance of some health, sexual and (non-)reproductive health intervention strategies. The contribution of family arrangements and motherhood was pointed out in the third theme along with the lack of studies that are not only centered in cis-heteronormativity. Therefore, we outline our snippet from a genealogical perspective in Latin American Psychology, highlighting the importance to think of and to implement strategies that are closer to the psychosocial, ethical and cultural realities of the region.

Cardiovascular disease (CVD) remains the leading cause of death in Western countries. Post-myocardial infarction heart failure can be considered a degenerative disease where myocyte loss outweighs any regenerative potential. In this scenario, regenerative biology and tissue engineering can provide effective solutions to repair the infarcted failing heart. The main strategies involve the use of stem and progenitor cells to regenerate/repair lost and dysfunctional tissue, administrated as a suspension or encapsulated in specific delivery systems. Several studies demonstrated that effectiveness of direct injection of cardiac stem cells (CSCs) is limited in humans by the hostile cardiac microenvironment and poor cell engraftment; therefore, the use of injectable hydrogel or pre-formed patches have been strongly advocated to obtain a better integration between delivered stem cells and host myocardial tissue. Several approaches were used to refine these types of constructs, trying to obtain an optimized functional scaffold. Despite the promising features of these stem cells’ delivery systems, few have reached the clinical practice. In this review, we summarize the advantages, and the novelty but also the current limitations of engineered patches and injectable hydrogels for tissue regenerative purposes, offering a perspective of how we believe tissue engineering should evolve to obtain the optimal delivery system applicable to the everyday clinical scenario.

Glycyrrhiza glabra L. is a native plant of Central and South-Western Asia that is also diffused in the Mediterranean area and contains several bioactive compounds such as: flavonoids, sterols, triterpene and saponins. Glycyrrhizin, containing glycyrrhizic and glycyrrhizinic acids has anti-inflammatory and antiallergic effects that are similar to corticosteroids. Ammonium glycyrrhizinate is a derivative salt of glycyrrhizic acid with similar anti-inflammatory activity that cannot pass through the skin due to its physicochemical properties and molecular weight. Although several nanoformulations, such as ethosomes, are designed to provide a systemic effect through a topical application, there are different limitations to the distribution inside the blood stream. For this reason, ultradeformable liposomes, or transfersomes, are selected to improve the topical delivery of drugs and allow the distribution of payloads in the blood stream because they pass intact through the stratum corneum epidermis barrier, due to the presence of sodium cholate, aqueous cutaneous gradient, and the rapid penetration of transfersomes by cutaneous tight junctions, thus allowing the systemic delivery of different therapeutic cargo in non-occlusive conditions. The aim of this work was the synthesis and physicochemical characterization of the ammonium glycyrrhizinate-loaded ultradeformable liposomes, the evaluation of drug release and permeation through stratum corneum and epidermis barrier. The in vivo anti-inflammatory effect of ammonium glycyrrhizinate-loaded ultradeformable liposomes was tested on human healthy volunteers. The results demonstrated that the ammonium glycyrrhizinate-loaded ultradeformable liposomes decreased the skin inflammation on the human volunteers and the resulting nanoformulations can be used as a potential topical drug delivery system for anti-inflammatory therapy. ☆Parts of these results were presented as a poster communication at the Recent Developments in Pharmaceutical Analysis 2019 (RDPA 2019), Chieti, Italy.

Inadequate therapies and clinical methods for overcoming multidrug-resistant cancer constitute the major barrier for cancer treatment. Also, early detection of this disease is fundamental and new nanotechnologies emerge with clear relevance. Considering their distinctive chemical and physical properties, plasmonic nanoparticles have been proposed and are regarded as promising carriers for cancer treatment. Gold nanoparticles (AuNPs) are the most studied plasmonic nanoparticles because of their special optical and electronic properties. Depending on size and shape, AuNPs are able to perform, simultaneously, several therapeutic functions, including photothermal therapy (PTT), photodynamic therapy (PDT), and imaging. The synergistic effect between PTT/PDT and chemotherapeutic drugs, to cooperatively suppress cancer cells, has also been studied, wherein rod-shaped AuNPs has been pointed out as suitable theranostic NP. This demonstrates their ability to integrate multiple functions in a single system. However, their performance is highly dependent on several experimental parameters including size, aspect ratio, surface modification, and morphology. All these parameters strongly affect both the physical and biological processes involved. This review focuses on AuNRs properties, their multiple applications, and the trends for the integration of theranostic applications. Also described are the difficulties imposed to an effective in vivo biodistribution and pharmacokinetic behavior. Current research and preclinical and clinical investigation will be addressed.

To investigate the short- and long-term effects of different combinations of dietary instructions on cariogenic food intake and salivary cariogenic bacteria (Streptococcus mutans [SM] and Lactobacillus [LB]).In this randomised 2-arm parallel study, 75 6-year-old subjects were assigned to repeated (group A; 19M/19F) or isolated (group B; 17M/20F) verbal and/or written dietary advice (VWDA), with foods classified by cariogenic potential. Both groups underwent a baseline salivary test for SM/LB, kept a monthly food diary, and attended 4 weekly visits (T1-T4). At T1-T2; group A only received VDA. At T3, both groups received VWDA. At T4, participants handed in their food diaries and underwent another salivary test. After 1 year (T5), subjects were recalled for weekly food diary monitoring and salivary testing. Relative risk (RR) of high-to-low SM/LB density was calculated at T4 and T5.Comparing groups A and B, VDA determined an increase in the intake of weakly cariogenic food (p0.05) and a decrease in that of intermediately cariogenic food (p0.05). After VWDA, a statistically significant increase in intake of weakly cariogenic food and a statistically significant decrease in the RR of high-density SM/LB colonies occurred in both groups. At T5, group A showed less intake of highly cariogenic food than did group B (p = 0.05) and persistent, although non-significant, reduction in the RR of high-density SM/LB colonies.Reinforcement measures on behavioural changes towards a noncariogenic diet not only help maintain long-lasting, healthier eating habits, but also decrease the cariogenic bacterial load in the short term, which tends to persist over time.

OBJECTIVES: To compare the effects on parathyroid hormone (PTH) and 25-hydroxy-vitamin D (25(OH)D) of two dosing regimens of cholecalciferol in women with secondary hyperparathyroidism (sHPTH) and hypovitaminosis D and to investigate variables affecting 25(OH)D response to cholecalciferol. DESIGN: Randomized-controlled trial with 6-month follow-up. SETTING: Two osteoporosis centers in northern Italy. PARTICIPANTS: Sixty community-dwelling women aged 65 and older with sHPTH and hypovitaminosis D, creatinine clearance greater than 65 mL/min and without diseases or drugs known to influence bone and vitamin D metabolism. INTERVENTION: Cholecalciferol 300,000 IU every 3 months, once at baseline and once at 3 months (intermittent D3 group) or cholecalciferol 1,000 IU/day (daily D3 group). MEASUREMENTS: Serum PTH, 25(OH)D, calcium, bone-specific alkaline phosphatase, β-C-terminal telopeptide of type I collagen, phosphate, 24-hour urinary calcium excretion. RESULTS: The two groups had similar baseline characteristics. All participants had vitamin D deficiency [25(OH)D

BACKGROUND The role of bisphosphonates (BPs) in the management of patients with hypercalciuria (HC) associated with osteoporosis is still uncertain. The aim of the study was to evaluate the effect of alendronate and indapamide alone or in combination on bone mineral density (BMD) and 24-h urinary calcium excretion (24-CaU) in post-menopausal women with HC and low BMD. METHODS A total of 77 post-menopausal women with HC (24-CaU > 4 mg/kg/day) and low BMD [T-score < -2.0 at lumbar spine (LS), femoral neck (FN) or total hip (TH)] from two centres of Northern Italy were randomized to receive indapamide 2.5 mg daily alone (24 patients, IND group), alendronate 70 mg weekly alone (27 patients, ALN group) or the combination therapy (26 patients, ALN + IND group). Throughout the study, all subjects received daily calcium supplements, depending on their dietary intake, to maintain a daily input of 1000 mg. Patients were instructed to increase water intake up to 2000 mL daily. The percentage and absolute changes of BMD at LS, FN and TH, and the variation of 24-CaU from baseline at 1 year were the primary outcomes. Serum calcium, phosphate, parathyroid hormone and bone alkaline phosphatase were also measured. RESULTS Overall 67 women completed the study and were included in the final analysis. Patients in the three groups were similar with regard to baseline characteristics. BMD did not significantly change from baseline after 1 year of treatment with indapamide (LS: +1 +/- 3.1%; FN: -0.3 +/- 3.5%; TH: -0.4 +/- 3.1%), while it showed a significant increase from baseline in the other two groups (ALN; LS: +5.8 +/- 4.2%, P < 0.001; FN: +3.9 +/- 7.9%, P = 0.018; TH: +2 +/- 3.6%, P = 0.006) (ALN + IND; LS: +8.2 +/- 5.3%, P < 0.001; FN: +4.9 +/- 6.7%, P = 0.007; TH: +2.9 +/- 4.2%, P = 0.004). Patients in the combination group showed a significantly higher increase of BMD at LS compared to ALN (P = 0.04). After 1 year, 24-CaU values significantly decreased from baseline in all groups (IND, 239 +/- 78 versus 364 +/- 44, P < 0.001) (ALN, 279 +/- 68 versus 379 +/- 79, P < 0.001) (ALN + IND, 191 +/- 68 versus 390 +/- 55, P < 0.001). The mean percentage decrease of 24-CaU in ALN + IND group (-50%) was significantly greater compared to ALN (-24%, P < 0.001) and IND (-35%, P = 0.012). CONCLUSIONS These results show a benefit, in terms of BMD improvement and 24-CaU reduction, associated with BPs' therapy in combination with indapamide in HC associated with osteoporosis. The combination therapy demonstrated a reduction of 24-CaU and an increase in LS BMD superior to that observed with alendronate alone. Our results support a new potential approach with BPs associated with thiazide diuretics or indapamide in the management of post-menopausal women with HC and associated bone loss. Studies on the larger sample size are needed to demonstrate the efficacy on the fracture outcome.

All hip fracture (HF) subjects are candidates for calcium and vitamin D (CaD) supplementation. Up to 50% of HF older adults present with secondary hyperparathyroidism (HPTH) resulting from hypovitaminosis D on hospital admission. To investigate the patterns and predictors of persistence with CaD supplementation in the elderly after HF, we considered all patients aged 70 years or older who were discharged alive after surgical repair of HF in the period of 1 year from an Orthopaedic Unit. Baseline characteristics of the subjects and osteoporosis treatment prescribed at discharge were retrieved from medical record review. A telephone interview at 6 months evaluated whether patients were currently taking CaD supplementation. Nonpersistence was defined when subjects ceased therapy within 6 months. Univariate and multivariate models were applied to determine the relationship between 6 months persistence with CaD and the variables collected: age, living situation, prescription of a bisphosphonate, baseline walking ability, number of drugs used, presence of dementia, number of active clinical issues at discharge (ACIs), discharge location, and being referred to a center for metabolic bone diseases (preplanned visit) at discharge. Of 428 subjects enrolled, 117 were excluded for different reasons (incomplete data, no therapy, death). A total of 311 subjects were discharged with a prescription of CaD (calcium 1,000 mg, cholecalciferol 800 UI, once daily) and were considered for the analysis. At 6 months, only 114 patients (36.7%) were currently taking CaD supplementation. In a univariate analysis, the following variables were significantly related with persistence: absence of dementia, prescription of a bisphosphonate, six or fewer drugs being used (drugs usedor=6), two or less ACIs (or=2 ACIs) at discharge, ability to walk without aid at baseline, being discharged home, and being referred to a preplanned visit. In a multivariate model, the prescription of a bisphosphonate at discharge (OR 3.178, 95% CI 1.477-6.836, P = 0.003), a preplanned visit (OR 1.953, 95% CI 1.066-3.514, P = 0.03), the absence of dementia (OR 1.877, 95% CI 1.021-3.451, P = 0.043), andor=6 drugs used (OR 1.842, 95% CI 1.066-3.182, P = 0.029) remained the most significant predictors of persistence with CaD. In HF elderly, who are at high risk of hypovitaminosis D and HPTH, persistence with CaD supplementation is very low. The enrolment in a postsurgical program for the management of bone disease can significantly increase persistence. Moreover, factors related to the complexity of older adult patients (polypharmacotherapy, dementia) seem to be particularly important in compliance with prescribed drugs.

OBJECTIVES: To determine whether secondary hyperparathyroidism (HPTH) due to hypovitaminosis D affects bone mineral density (BMD) response to alendronate (ALN) in elderly women with osteoporosis. DESIGN: Randomized, controlled trial with 1-year follow-up. SETTING: Two osteoporosis centers in northern Italy. PARTICIPANTS: Community-dwelling women aged 60 and older with a BMD T-score below -2.5 and secondary HPTH with vitamin D insufficiency. INTERVENTION: One hundred twenty subjects were randomly assigned to receive ALN 70 mg once a week alone or ALN 70 mg once a week plus calcitriol (1,25D3) 0.5 microg daily. MEASUREMENTS: BMD measured using dual-energy x-ray absorptiometry at the lumbar spine (L1-L4), femoral neck, and total hip and serum levels of intact PTH at baseline and 12 months. RESULTS: After 1 year, BMD of the lumbar spine, femoral neck, and total hip significantly increased from baseline in both groups (P

Giusti A, Barone A, Oliveri M, Pizzonia M, Razzano M, Palummeri E, Pioli G. An analysis of the feasibility of home rehabilitation among elderly people with proximal femoral fractures. Objective To evaluate the feasibility and predictors of success of home-based rehabilitation (HBR) in older adults after hip fracture. Design Prospective inception cohort study with 12 months of follow-up. Setting Acute and subacute care with follow-up in a community setting in Italy. Participants Community-dwelling older adults (N=199) aged 70 years or older, discharged from an acute orthopedic unit after repair of a nontraumatic proximal femoral fracture. Interventions Patients' choice of pursuing HBR or institutional-based rehabilitation (IBR). Main Outcome Measures Proportion of subjects discharged home for rehabilitation. Rates of institutionalization assessed at 3, 6, and 12 months postdischarge. Mean changes of the Barthel Index from baseline and proportion of subjects who regained their prefracture levels of function at the time of follow-up in the 2 intervention groups (HBR, IBR). Results Ninety-nine (49.7%) patients chose HBR, and the rest (50.3%) were discharged to a rehabilitation facility. With regard to the baseline characteristics, the 2 patient groups (HBR, IBR) differed with respect to living arrangement ( P ≤.001), prefracture functional status in basic (Barthel Index, P =.033; Katz Index, P =.041) and instrumental activities of daily living (IADLs) ( P =.041), and occurrence of delirium ( P =.022). During the follow-up, the number of subjects institutionalized at 3, 6, and 12 months was 52, 26, and 22, respectively. In the multiple logistic regression model, the only significant variable affecting the choice of IBR at discharge was the absence of relatives at home (odds ratio [OR], 6.7; 95% confidence interval [CI], 3.33–13.46; P ≤.001), whereas a prefracture functional impairment in more than 3 IADLs (at 12mo: OR=3.99; 95% CI, 1.57–10.18; P =.004), the absence of relatives at home (at 12mo: OR=8.81; 95% CI, 2.47–31.46; P =.001), and delay to surgery longer than 3 days (at 12 mo: OR=5.51; 95% CI, 1.28–23.81; P =.022) resulted in significant risk factors for long-term institutionalization. Compared with subjects who received traditional rehabilitation, those discharged home showed—after controlling for prefracture Barthel Index score, IADLs, cognitive status and age—a slightly lower functional decline and a higher rate of recovery during the follow-up (mean change in Barthel Index score ± standard deviation at 12mo: HBR, −11.2±24.7 vs IBR, −23.7±28.5; P =.015). Conclusions In an unselected population of hip-fractured older adults previously living in the community, HBR seems to be a feasible alternative to IBR in those subjects living with relatives.

Whether elderly patients with asymptomatic or minimally symptomatic primary hyperparathyroidism (PHPT) should be treated or not is still under debate. Several literature reports have shown improvements in terms of bone density and physical and mental well-being after surgical resolution of PHPT. Here, we present the case of a 93-year-old hypertensive woman, who had suffered for one year from cognitive impairment, accompanied during the last month by behavioral alterations (and polyuria and polydipsia), which resulted in sopor leading to hospitalization. A CT brain scan evidenced cortical atrophy and cerebrovascular disease, and biochemical analyses were remarkable for hypercalcemia (11.4-12.6 mg/dL, corrected for albumin levels) associated with increased parathormone levels (95.4-100.6 pg/mL). A diagnosis of PHPT was established. Densitometry evaluation of radius showed osteopenia. Withdrawal of psycho-therapy drugs and thiazidic, together with i.v. saline hydration and loop diuretics, significantly improved the patient's mental state and resolved behavioral alterations. As the patient and her relatives refused the surgical option, and the clinical situation improved after medical normalization of calcium levels, PHPT was managed conservatively, and calcium levels were maintained within the normal range through i.v. administration of zoledronate at 8-week intervals. Our case highlights the importance of considering hypercalcemia as the cause of onset of behavioral alterations and worsening of mental condition in elderly patients with cognitive decline. Therapy with bisphosphonates in patients with PHPT who are unfit for or refuse surgery seems advisable, but needs further study.

This document is a Joint Position Statement by Gruppo Italiano di OrtoGeriatria (GIOG) supported by Societa Italiana di Gerontologia e Geriatria (SIGG), and Associazione Italiana Psicogeriatria (AIP) on management of hip fracture older patients. Orthogeriatric care is at present the best model of care to improve results in older patients after hip fracture. The implementation of orthogeriatric model of care, based on the collaboration between orthopaedic surgeons and geriatricians, must take into account the local availability of resources and facilities and should be integrated into the local context. At the same time the programme must be based on the best available evidences and planned following accepted quality standards that ensure the efficacy of the intervention. The position paper focused on eight quality standards for the management of hip fracture older patients in orthogeriatric model of care. The GIOG promotes the development of a clinic database with the aim of obtaining a qualitative improvement in the management of hip fracture.

Introduction The recent improvement in the resolution of dual-energy X-ray absorptiometry (DXA) images enables most vertebral levels to be seen adequately and thus DXA may be a worthwhile alternative to radiologic morphometry for the identification of vertebral fractures (VF). In this multicenter study, we have derived reference data for vertebral heights and their ratios in Italian women using morphometric X-ray absorptiometry (MXA). Methods DXA scans were acquired in 1254 consecutive pre- and postmenopausal women, (mean age 63.7 ± 11.3, range 26–88 yrs), referred to six osteoporosis centers. MXA analysis of these images was performed by the same operator measuring vertebral heights and height ratios from L4 to T4. We calculated measures of central tendency and dispersion of vertebral heights and vertebral ratios using different approaches (mean and standard deviation as well as median and interquartile range of raw data, mean and standard deviation of trimmed data using an iterative algorithm, and mean and standard deviation of not fractured vertebrae). Results Independently of the approach that we used, all the measures of central tendency were similar, while significant differences were found when compared with reference ranges in other populations. The vertebral heights of our sample at every vertebral level were significantly smaller than both Rea population and the Lunar reference values, even after normalization. Splitting data according to age groups, there was a decrease in the vertebral heights and ratios between the younger and older women. Conclusions This study demonstrates that reference data for MXA should be population specific and age matched.

To compare the effects on parathyroid hormone (PTH) and 25-hydroxy-vitamin D (25(OH)D) of two dosing regimens of cholecalciferol in women with secondary hyperparathyroidism (sHPTH) and hypovitaminosis D and to investigate variables affecting 25(OH)D response to cholecalciferol.Randomized-controlled trial with 6-month follow-up.Two osteoporosis centers in northern Italy.Sixty community-dwelling women aged 65 and older with sHPTH and hypovitaminosis D, creatinine clearance greater than 65 mL/min and without diseases or drugs known to influence bone and vitamin D metabolism.Cholecalciferol 300,000 IU every 3 months, once at baseline and once at 3 months (intermittent D(3) group) or cholecalciferol 1,000 IU/day (daily D(3) group).Serum PTH, 25(OH)D, calcium, bone-specific alkaline phosphatase, β-C-terminal telopeptide of type I collagen, phosphate, 24-hour urinary calcium excretion.The two groups had similar baseline characteristics. All participants had vitamin D deficiency [25(OH)D20 ng/mL)], and 36 subjects (60%) had severe deficiency (10 ng/mL), with no difference between the groups (severe deficiency: intermittent D(3) group, n=18; daily D(3) group, n=18). After 3 and 6 months, both groups had a significant increase in 25(OH)D and a reduction in PTH. Mean absolute increase ± standard deviation of 25(OH)D at 6 months was higher in the intermittent D(3) group (22.7±11.8 ng/mL) than in the daily D(3) group (13.7±6.7 ng/mL, P.001), with a higher proportion of participants in the intermittent D(3) group reaching desirable serum concentration of 25(OH)D≥30 ng/mL (55% in the intermittent D(3) group vs 20% in the daily D(3) group, P.001). Mean percentage decrease of PTH in the two groups was comparable, and at 6 months, a similar proportion of participants reached normal PTH values. 25(OH)D response to cholecalciferol showed a wide variability. In a logistic regression analysis, body mass index and type of treatment appeared to be significantly associated with normalization of 25(OH)D values.Cholecalciferol 300,000 IU every 3 months was more effective than 1,000 IU daily in correcting vitamin D deficiency, although the two groups achieved similar effects on PTH at 6 months. Only 55% of the higher-dose intermittent group reached desirable concentrations of 25(OH)D, suggesting that yet-higher doses will be required for adequate vitamin D repletion.

Idiopathic hypercalciuria (IHC) is defined as a 24-hour urinary calcium excretion that exceeds 4 mg/kg/day, regardless of gender and in absence of systemic diseases or pharmacological treatments that may cause normocalcemic hypercalciuria (eg sarcoidosis, normocalcemic primary hyperparathyroidism, vitamin D intoxication, hyperthyroidism). Patients with IHC and nephrolithiasis often present increased bone turnover, decreased bone mineral density (BMD) and increased susceptibility to fragility fractures. Although the pathogenesis of IHC seems complex and multifactorial, recent evidences suggest that cells involved in bone resorption may play a critical role in the chain of events leading to the excessive urinary calcium excretion. Therefore, it has been proposed that bisphosphonates, potent inhibitors of bone resorption, may have beneficial effects in hypercalciuric patients with low BMD. This manuscript reports recent findings regarding the role of bone tissue in the pathogenesis of IHC, and supports the use of bisphosphonates in such conditions. It also reviews the literature on the effects of bisphosphonates in subjects with osteoporosis-associated IHC.

Changes in bone mineral density and bone strength following treatment with zoledronic acid (ZOL) were measured by quantitative computed analysis (QCT) or dual-energy X-ray absorptiometry (DXA). ZOL treatment increased spine and hip BMD vs placebo, assessed by QCT and DXA. Changes in trabecular bone resulted in increased bone strength.To investigate bone mineral density (BMD) changes in trabecular and cortical bone, estimated by quantitative computed analysis (QCT) or dual-energy X-ray absorptiometry (DXA), and whether zoledronic acid 5 mg (ZOL) affects bone strength.In 233 women from a randomized, controlled trial of once-yearly ZOL, lumbar spine, total hip, femoral neck, and trochanter were assessed by DXA and QCT (baseline, Month 36). Mean percentage changes from baseline and between-treatment differences (ZOL vs placebo, t-test) were evaluated.Mean between-treatment differences for lumbar spine BMD were significant by DXA (7.0%, p0.01) and QCT (5.7%, p0.0001). Between-treatment differences were significant for trabecular spine (p = 0.0017) [non-parametric test], trabecular trochanter (10.7%, p0.0001), total hip (10.8%, p0.0001), and compressive strength indices at femoral neck (8.6%, p = 0.0001), and trochanter (14.1%, p0.0001).Once-yearly ZOL increased hip and spine BMD vs placebo, assessed by QCT vs DXA. Changes in trabecular bone resulted in increased indices of compressive strength.

Barone A, Giusti A, Pizzonia M, Razzano M, Oliveri M, Palummeri E, Pioli G. Factors associated with an immediate weight-bearing and early ambulation program for older adults after hip fracture repair. Objective To evaluate baseline characteristics and in-hospital factors associated with nonadherence with an immediate weight-bearing and early ambulation (IWB-EA) program after hip fracture (HF) surgery. Design Prospective inception cohort study. Setting Ortho-geriatric unit in an acute care hospital. Participants Older adults (N=469) admitted with an osteoporotic HF who underwent surgery. Interventions Immediate weight-bearing and assisted ambulation training on the first postoperative day (all patients). Main Outcome Measure Proportion of subjects who adhered to the IWB-EA protocol within 48 hours of surgery. Results A total of 366 patients (78%) bore weight and ambulated within 48 hours (weight-bearing [WB] group) while the others did not adhere to the protocol (nonweight-bearing [NWB] group). Subjects in the NWB group were significantly older, were more cognitively and functionally impaired, and presented a higher comorbidity at baseline. A higher proportion of subjects in the NWB group (42.7%) than the WB group (23.5%; P Conclusions This study establishes that IWB-EA is feasible in a high proportion of patients after surgical stabilization of HF. Neither cognitive impairment nor high comorbidity influenced significantly the adherence to the protocol, indicating that IWB-EA may be offered to an unselected population of the elderly with HF. The day of surgery (eg, preholiday or not) was the only variable influencing the participation to the IWB-EA protocol, suggesting the importance of maintaining the same standard of daytime care every day of the week.

L’osteoporosi e definita, per entrambi i sessi, come una malattia sistemica dello scheletro caratterizzata da una riduzione della massa ossea e dalla compromissione della microarchitettura scheletrica tali da predisporre a un aumentato rischio di frattura [1]. La frattura da fragilita rappresenta quindi la principale conseguenza clinica dell’osteoporosi.

Background and aims: Few studies have investigated predictors for hospital readmission after hip fracture repair. Methods: In a prospective cohort study we evaluated factors associated with early (within 3 months) and late (between 3–12 months), single and multiple hospital readmission in 236 hip-fractured older adults admitted to an orthopedic unit. Baseline patient characteristics and hospital course (functional and cognitive status, comorbidity, type of fracture, time to surgery, in-hospital stay, complications) were recorded. Hospital readmission over 12 months and ICD-9 principal diagnosis were ascertained from administrative sources. Functional status at the end of the rehabilitation program was assessed by telephone interviews. Results: Seventy-one patients (30.1%) were readmitted to hospital within twelve months of discharge and 22 (9.3%) had two or more readmission. The total number of readmissions was 105, 43 (41%) occurred in the first three months. The most common readmission causes were cardiac, infectious and cerebrovascular; surgical complication accounted for 5.7%. Patients with a single readmission, like those with multiple readmissions, were sicker (CIRS-CIsubscore 4.0±1.8 vs 3.2±1.6, p=0.010) and more functionally impaired at the end of rehabilitation (2 months’ Katz index 2.1±2 vs 2.9±2.3, p=0.007) than controls. In a multiple logistic regression model, comorbidity and functional status at the end of rehabilitation were the only factors associated with the risk of readmission. Conclusions: Subjects at high risk of readmission can be reliably assessed, since few significant variables were associated with rehospitalization. Subgroups of patients with an elevated risk of rehospitalization after hip fracture may be the target for strategies to reduce the burden of excessive hospital use and improve overall outcomes.

Hip fracture (HF) is a major health care problem in the Western world, associated with significant morbidity, mortality and loss of function. Its incidence is expected to increase as the population ages. The authors discuss the role of a coordinated multidisciplinary team in the management of patients during hospital stay, at discharge and during rehabilitation. Orthogeriatric care should not just be viewed as a multidisciplinary activity, but as a radical alternative to the traditional model of care, an alternative based on all those strategies in which evidence shows an improvement in outcomes in the fractured elderly. Therefore, key points of the care are early surgery, immediate mobilization, prevention and management of delirium, pain and malnutrition, as well as an integrated and multidisciplinary approach. Comprehensive geriatric assessment is useful in identifying frail elderly and in providing information that is essential in formulating clinical recommendations and making care plans. In each hospital, the orthogeriatric unit should represent a center of excellence for treating elderly patients with major fractures. However, when an orthogeriatric project is implemented, it is essential that detailed data about the case-mix of patients, process of care and outcomes are collected, to compare the results with historical data and to be able to participate in audit processes.

To determine whether secondary hyperparathyroidism (HPTH) due to hypovitaminosis D affects bone mineral density (BMD) response to alendronate (ALN) in elderly women with osteoporosis.Randomized, controlled trial with 1-year follow-up.Two osteoporosis centers in northern Italy.Community-dwelling women aged 60 and older with a BMD T-score below -2.5 and secondary HPTH with vitamin D insufficiency.One hundred twenty subjects were randomly assigned to receive ALN 70 mg once a week alone or ALN 70 mg once a week plus calcitriol (1,25D3) 0.5 microg daily.BMD measured using dual-energy x-ray absorptiometry at the lumbar spine (L1-L4), femoral neck, and total hip and serum levels of intact PTH at baseline and 12 months.After 1 year, BMD of the lumbar spine, femoral neck, and total hip significantly increased from baseline in both groups (P.001). Patients allocated to ALN plus 1,25D3 demonstrated a significantly higher increase in lumbar spine BMD than those receiving ALN alone (mean percentage+/-standard deviation 6.8+/-4.6 vs 3.7+/-3.2, P.001). Serum levels of PTH did not change significantly at 1 year in the ALN group (mean percentage, -3.7+/-27.1, P=.13) but decreased significantly in the ALN plus 1,25D3 group (-32.1+/-22.1, P.001). At 12 months, subjects with normalized PTH independent of therapy allocation had a greater increase in lumbar spine BMD than those with persistent HPTH (6.5+/-4.6% vs 3.7+/-3.4%, P.001). Lumbar spine BMD changes showed a significant negative correlation with PTH at 1 year (correlation coefficient (rho) =-0.399, P.001) and a positive correlation with PTH changes (i.e., baseline value - 1 year value; rho=0.295, P=.005).Persistence of secondary HPTH reduces BMD response to ALN in older women with osteoporosis.

Background and aims: The study investigates one-year mortality risk associated with hip fracture in elderly people, and pre-fracture characteristics and events occurring during the acute phase which may represent significant predictors for acute and long-term mortality. Methods: The study is a prospective cohort study of 252 patients aged 70 and older, consecutively admitted with hip fracture to the Division of Orthopedic Surgery of the Galliera Hospital of Genoa, Italy. At admission, each subject received a standardized diagnostic evaluation, including demographic variables, biochemical markers of nutritional status and basic medical, functional and cognitive assessment. Patients were followed by telephone interviews at three months, six months and one year after fracture. The relationship between mortality and the risk factors recorded was assessed using logistic regression models. Results: 248 patients were eligible. Cumulative mortality was 4.8% during hospital stay, and 12.5% at 3, 18.9% at 6 and 24% at 12 months. The risk factors significantly associated with mortality were: sex, Acute Physiology Score (APS), comorbidity, functional and cognitive status, and albumin levels. In multivariate models, albumin below 3 g/dL remained the only significant predictor of in-hospital mortality (OR 6,8, 95% CI 1.56-29,7, p

Objectives: To determine and compare the prevalence of secondary hyperparathyroidism (HPTH) in a population of community-dwelling and institutionalized older adults hospitalized with and without hip fracture, and to evaluate factors correlated with secondary HPTH in this population. Methods: Circulating concentrations of serum intact PTH, 25-hydroxyvitamin D [25(OH)D] total serum calcium and albumin were measured in 160 subjects with an osteoporotic fracture of the proximal femur and in 160 matched controls hospitalized for a disease unrelated to bone status. Patients with secondary causes of bone loss and taking medications affecting bone metabolism were excluded. Age, sex, place of residence and the ability to perform basic activities of daily living (BADL) two weeks before hospital admission were recorded at baseline. Results: Patients were comparable with regard to the baseline demographic, biochemical and functional characteristics. The overall prevalence of secondary hyperparathyroidism was 51.2%, without significant differences between hip fractured patients and controls (50.6 vs 51.9%, p=0.911). In bivariate analysis only the age and functional status (BADL) demonstrated a significant relationship with secondary HPTH, while sex and place of residence were not significant. These results were also confirmed in multivariate analysis. Particularly, the risk of secondary HPTH increased with age and with the number of functions lost in BADL: patients fully dependent showed a 3 times as high risk (odd ratio 3.07, 95% confidence interval 1.73 to 5.46, p=0.000) compared to patients independent in BADL, and subject aged >88 yr had a twice as high risk of developing secondary HPTH compared to younger ones (odd ratio 2.28, 95% confidence interval 1.20 to 4.32, p=0.012). Conclusion: These results show that secondary HPTH due to hypovitaminosis D is a frequent disorder in hospitalized elderly, strongly correlated with the functional status, irrespective of sex and place of residence.

Dear Editor, In a recent issue of Osteoporosis International Sakuma et al. demonstrated a higher prevalence of hypovitaminosis D and secondary hyperparathyroidism (sHPTH) in elderly patients with hip fracture than in non-osteoporotic controls [1]. One of the conclusions of the authors was that serum 25hydroxyvitamin D (25-OHD) may be a useful index to identify elderly at high risk of hip fracture. We found these results interesting and, although in agreement to some degree, we would raise some issues in order to contribute to the topic. It is well established that, in the general population, the frequency of vitamin D deficiency and sHPTH increase with the age and are higher in subjects with functional disability [2]. In the study by Sakuma et al., patients with femoral fracture were older compared to controls, and their serum level of 25-OHD was related to the degree of functional dependence. However, no comparison of baseline functional status between the two groups was reported. Moreover, hip fractured subjects presented serum albumin levels significantly lower than controls, with the difference being significant even after controlling for age. In elderly people, serum albumin is considered to be a marker of frailty rather than a simple nutritional index – a term commonly used to describe elderly individuals particularly vulnerable to falls, disability and premature death [3]. A spontaneous consideration arising from these observations is that patients in the hip fracture group not only were more likely to have sHPTH and hypovitaminosis D, but, more importantly, presented a higher degree of frailty compared to controls. Consistent with these observations, we have recently demonstrated, in a cohort of older adults with and without hip fracture, a strong correlation between the ability to perform basic activities of daily living (BADLs) and sHPTH due to hypovitaminosis D [4]. Moreover, in our report, after normalizing for age and baseline functional status, there was no significant difference in terms of prevalence of sHPTH between hip fractured subjects and matched controls. It, therefore, seems that 25-OHD deficiency and sHPTH, along with serum albumin, more than simple risk factors for hip fracture, may be considered to be a useful index to identify vulnerable and frail older adults. In support to these hypotheses, it must be noted that some studies have demonstrated a strong correlation between sHPTH, due to hypovitaminosis D, and a number of adverse outcomes in elderly subjects [5, 6]. Di Monaco et al. found that PTH and 25-OHD, acting through independent mechanisms, were significantly associated with the functional recovery after hip fracture [5]. Furthermore, Sambrook and colleagues found that PTH was significantly associated with increased mortality in older adults residing in hostels and nursing homes, independently of renal function, bone mass and vitamin D status [6]. Osteoporos Int (2007) 18:1561–1562 DOI 10.1007/s00198-007-0395-z

A well-known in vivo mouse model for postmenopausal osteoporosis is the ovariectomized (OVX)mousemodel, commonly used to study the effect of treatments. Although many studies have investigated the treatment of osteoporosis with parathyroid hormone (PTH), some information is lacking about several histomorphometric parameters, non-collagen protein expression, Ca/P ratio, and mechanical properties in this particular model. The aim of this study was to investigate the effect of PTH through histological, biochemical, histomorphometric and mechanical analyses in OVX mice. To simulate postmenopausal osteoporosis, forty C57BL/6 female mice (15 w old) were ovariectomized. A subcutaneous injection of PTH (hPTH 1–34, Bachem AG, Switzerland) or just vehicle was administered daily. To explore structural changes and bone loss with time in vivo, microtomographic scans of the sixth caudal vertebra (C6) were performed from the day of surgery till the end of the experiment. Histomorphometric, histological, western blotting (wb), immunohistochemical and energy dispersive X-ray (EDX) analyses were performed on one femur to investigate trabecular and cortical thickness, the mineral apposition rate (MAR), osteoid and osteoclast surface, osteocytes apoptosis, osteopontin (OP) and osteocalcin (OC) expression and Ca/P ratio. On the contralateral bone one 4-point bending tests were performed to determine the mechanical stiffness in four directions and the failure strength of the diaphysis. Furthermore, a fracture test of the femoral neck was performed. Comparing the PTHgroup to thevehicle: themicroCTanalysis demonstratedaweak increase over time only in trabecular thickness in the C6, up to ~10% at the time of sacrifice; histology and histomorphometry revealed significant increase in trabecular and cortical thickness (~45% and ~15%, respectively), the MAR increased (~20%), the osteoid surface strongly increased (~60%) together with the osteoclast surface and the number of apoptotic osteocytes greatly decreased (~60%); wb showed no significant difference in OP content, while immunohistochemistry revealed a strong increase of OC (~80%); EDX showedno significant variation in Ca/P content. All mechanical properties significantly increased (10–20%). These findings demonstrate that PTH treatment positively affects biochemical, histomorphometric and mechanical properties of this mouse model. This work was funded by the European Community (project no.: FP7-223865, acronym VPHOP). This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: None declared. doi:10.1016/j.bone.2011.03.489 PP359-M Sustained increase in bone mineral density with alendronate in combination with indapamide in postmenopausal women with idiopathic hypercalciuria associated to osteoporosis: A 1-year randomized trial followed by a 2-year extension A. Giusti ⁎, A. Barone , G. Girasole , M. Razzano , M. Plzzonia , E. Palummeri , M. Pedrazzoni , G. Bianchi , G. Pioli d a Gerontology, Galliera Hospital, Genoa, Italy b Rheumatology, La Colletta Hospital, Arenzano, Italy c Internal Medicine, Parma University, Parma, Italy d Geriatrics, ASMN Hospital, Reggio nell'Emilia, Italy Abstract: Introduction: A recent 1-year randomized trial (Giusti A et al., NDT 2009) demonstrated the beneficial effect of alendronate (ALN)+indapamide (IND) in the treatment of women with idiopathic hypercalciuria (IHC) and associated bone loss. Methods: To evaluate the effect of ALN alone or in combination with IND on bone mineral density (BMD) and 24-hour urinary calciumexcretion (CaU), 77 postmenopausalwomenwith CaU>4mg/ kg/die and low BMD were randomized to receive for 1-year: indapamide 2.5 mg/daily alone (24 patients, IND group), alendronate 70mg/weekly alone (27 patients, ALN group) or the combination therapy (26 patients, ALN+IND group). 50 women (IND: 14, ALN: 17, ALN+IND: 19) who completed the first yearandconsented toparticipatewereenrolled ina2-yearextension.All subjects received daily calcium supplements to maintain a daily input of 1000mg, and were instructed to increase water intake up to 2000ml daily. The percentage change of BMD at lumbar spine (LS), femoral neck (FN) and total hip (TH) after 3-year, and the variation of 24-hour CaU from baseline at 2-year were the primary outcomes. Serum calcium, PTH and bone alkaline phosphatase were also measured. Results: After 2-year CaU values significantly decreased from baseline in all groups (IND, 210±89vs382±54,p

Introduction.We explored the prevalence of vitamin D deficiency and secondary hyperparathyroidism(sHPTH) ina case–control studyof100HIV-infectedpatients (HIV) and100 matched controls.Methods. HIVwere included if theywere naive to antiretroviral therapy (ART) or receiving first line ART. Healthy controls were matched for age (age range 25–65 years) and gender. Subjects, recruited between February–April 2009, underwent a standardized assessment to evaluate demographic and anthropometric characteristics, bone mineral density (BMD), serum calcium, phosphate, 25-hydroxy-vitamin D (25OHD), PTH, markers of bone turnover, clinical history and ART regimens (HIV only). The proportion of patientswith 25OHD 65 pg/ml was calculated. Secondary analyses were undertaken to evaluate variables associated with vitamin D deficiency in HIV. Results. The two groups were comparable with regard to baseline characteristics, except for alcohol intake, level of physical activity and prevalence of fractures. A significantly greater proportion (p =20), reclassification analyses showed that the GFRC reclassified more patients who sustaineda fracture to higher risk categories (85.4%), but alsomorepatientswhodidnot sustain a fracture (68.7%). Therefore, net reclassification was not significant (p>0.05, Table 1). Even after correction of the 10-year risk of FRAX (1/(major fractures/all fractures)=1/(36/ 48)=1.33) the results remained the same, and also when BMD was not included (data not shown). Discussion: GFRC, compared with FRAX, resulted in significantly higher fracture risks for women who did and did not sustain a fracture after baseline. GFRC reclassified significantly more women who did sustain a fracture to higher risk categories. However, the net reclassification was not significant. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: None declared. doi:10.1016/j.bone.2011.03.054 OC03/AHP03 Adherence to recommendations for fall prevention significantly affects the risk of falling after hip fracture in older women M. Di Monaco , C. Castiglioni ⁎, F. Vallero , E. De Toma , L. De Lauso , R. Tappero c a Osteoporosis Research Center, Presidio Sanitario San Camillo, Torino, Italy