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Objective: This study aimed to compare the efficacy and safety of ossein-hydroxyapatite complex (OHC) versus calcium carbonate (CC) for preventing bone loss during perimenopause in current clinical practice.Methods: The prospective, comparative, non-randomized, open-label study included 851 perimenopausal women with basal bone mineral density (BMD) T-score ≥-2 standard deviations (SDs). Participants received either OHC (712 mg calcium/day) or CC (1000 mg calcium/day) over 3 years. BMD was evaluated by dual-energy X-ray absorptiometry at the lumbar spine (L2-L4) at baseline and after 18 and 36 months of follow-up. Adverse drug reactions (ADRs) were also recorded.Results: In women receiving OHC, BMD at the L2-L4 site remained stable over the 3-year follow-up period (mean [SD] change 0.00 [0.11] g/cm2). BMD in the CC arm decreased -3.1% (mean [SD] - 0.03 [0.11] g/cm2). Between-group differences were statistically significant (p

Background: The prevalence of rheumatic diseases in the Spanish population is estimated at 22.6% according to the EPISER 2000 study. A new epidemiological study is currently underway, EPISER 2016 and its preliminary results point towards a higher prevalence. Within the national health system, primary care is the first level of access to the health system and is provided at primary care centers (CAP). The rheumatology at primary care centers at Spain has been a pioneer in the application from the team at Parc de Salut Mar (Hospital del Mar), with the physical presence of rheumatologists in the 14 centers belonging to the CAP network of the SAP Litoral. The high prevalence of the medical pathology of the musculoskeletal syste and the aging of the population, can condition an increase in visit requests in rheumatology, and with it, the increase in the waiting lists of patients. Objectives: The main objective of this study is to know the resolutive possibility of virtualization, measured in the number of visits resolved telematically, as well as its impact on the resolution capacity of the primary care physician and the reduction of the waiting list of first face-to-face visits. Methods: Prospective experimental study, started on December 1, 2017 and ended on May 31, 2018. Four primary care centers were selected according to population and waiting list: Sant Marti Nord, Sant Marti Sud, Ramon Turro and Villa Olimpica. The REVIR program proposes the creation of a circuit for the assessment of referrals to rheumatology from primary care physicians (MAP). Results: 726 first visit requests were received during the REVIR program. The most common categorized pathology was mechanical pathology, representing about 70% of the first visits requested. Metabolic bone disease ranked second with 16%, and inflammatory pathology ranked third (SLE, RA, SA, SPA, PsA). Chronic musculoskeletal pain ranked fourth (including fibromyalgia) and lastly soft tissue pathology. The number of first visit requests was multiplied by two in all the participating primary care centers of the project. Despite this increase, the telematic resolution of the visits created was stable, with a value greater than 40%. Conclusion: The implementation of a system of assessment of the first visits in rheumatology requested from Primary Care is effective in decreasing the waiting list to make face-to-face visits, as well as to detect early serious pathology that requires hospital control. It has been achieved, therefore, that the patient is treated at the level of attention that corresponds to him. Guaranteeing the adequate use of hospital resources and reducing the waiting list for a first in-person visit in rheumatology in primary care is one of the most important goals fulfilled, given that it is directly related to maintaining the accessibility and equity of the public health system. References: [1] Kataria, S., & Ravindran, V. (2018). Digital health: a new dimension in rheumatology patient care. Rheumatology International. https://doi.org/10.1007/s00296-018-4037- Disclosure of Interests: Fabiola Ojeda: None declared, Manel Ciria: None declared, Carolina Perez-Garcia: None declared, Eric Sitjas: None declared, Elena Martinez: None declared, Daniel Martinez-Laguna Speakers bureau: Eli Lilly, Amgen, Ferrer, Rubio and Novartis., Montserrat Pimienta: None declared, Jordi Monfort: None declared

Background:Inflammatory myopathies (IM) are a group of rare diseases that involve muscle inflammation. Several types are defined with a wide range of different manifestations and prognosis.Objectives:Describe the characteristics of the cohort of patients with IM in a tertiary hospital, in order to identify their demographic and clinical characteristics and try to find a correlation between them.Methods:Retrospective observational study of patients with IM: dermatomyositis (DM), polymyositis, antisynthetase syndrome (ASS), necrotizing autoimmune myopathy and overlap syndrome (OS). Clinical, biological, neurophysio and histopathological data were collected. Statistical analysis was performed using SPSS 23 IBM®.Results:28 patients were included with a follow-up of 10.9 ± 9.8 years (y). According to the 2017 EULAR / ACR criteria for IM, 89.2% were classified as definitive MI, with an average score of 12.1 ± 3.2. Age at diagnosis 47.3 ± 17.7y; ratio 1.3; 78.6% Caucasian, 10.7% Asian and 10.7% Latino. 39.3% had DM, 3.6% hypomyopathic and 3.6% amyopathic DM, 28.6% OS and 17.9% ASS. Lung involvement was the most prevalent extramuscular manifestation (67.9%). Systemic sclerosis was the most frequent overlapping autoimmune disease (AD) (21.4%) and 2 patients (7.1%) overlapped more than 1 AD. In Table 1 are detailed the clinical characteristics of the patients, and in Figures 1 and 2, the autoantibody (aa) profile and treatments used. The incidence of neoplasm was 10.7% 10.3 ± 9.6y after the diagnosis of myopathy (3 breast neoplasms, 1 colon and 1 cutaneous lymphoma), and of them, 66.7% had two synchronous neoplasms. No neoplasms were observed in the 2 anti-TIF1-γ+ patients. The subtype of IM in these patients was 1 OS anti-RNP+, 1 DM anti-PL-12+ and 1 ASS anti-OJ+. 17.9% smoked and 21.4% had taken statins at some point, without it being related to the start of the myopathic clinic. A capillaroscopy was performed in 67.9%, being pathological in 63.1%The positivity of anti-RNP (p=0.01) and steroid bolus (p=0.039) were correlated with a more severe disease, defined as a summation index composed of a series of manifestations (pulmonary hypertension (PH), ischemic heart disease, venous/arterial thrombosis, myo/pericarditis, interstitial lung disease (ILD), severe infections, neoplasms or hospitalizations). Other statistically significant correlations between aa and clinical manifestations are detailed in Table 3, among which the anti-RNP+ with myopericarditis stands out. No correlation was found between the findings on capillaroscopy and the type of IM.Conclusion:The most frequent subtype of IM was DM. 10.3% of the patients presented a neoplasm, all with different subtypes of myopathy and aa. The presence of anti-RNP+ correlated with greater severity of the disease and myopericarditis. Likewise, significant differences were found between the subtypes of aa and certain clinical manifestations. There is no correlation between findings on capillaroscopy and the type of IM.Table 1.Clinical characteristics.Clinical manifestationsFrequency %PresentationAcute40.7Subacute22.2Insidious37Muscular Weakness82.1Muscle Enzymes Elevation85.7Muscle Pain67.9Joint Manifestations (Mf)67.9Systemic Mf67.9Digestive Mf46.4Raynaud’s Syndrome (RS)53.6Sclerodactyly32Digital ulcers (DU)25Calcinosis10.7ILD67.9Nonspecific Interstitial Pneumonia63.2Usual Interstitial Pneumonia15.8Organizing Pneumonia10.5Lymphocytic Interstitial Pneumonia5.3Undefined Pattern5.3PH10.7Serious Infections17.9Figure 1.Aa.Figure 2.Treatment.Table 2.Correlations between clinical manifestations and aa.ManifestationsAutoantibodiesp valueDUAnti-MDA50.005SclerodactylyAnti-RNP0.011PericarditisAnti-RNP0.000MyocarditisAnti-RNP0.005DiabetesAnti-RNP0.027RSAnti-PM/Scl0.033CalcinosisAnti-PM/Scl0.027Flexion ContracturesAnti-PM/Scl0.027ArrhythmiasAnti-PL-120.001Disclosure of Interests:Irene Carrión Barberà Grant/research support from: I received a grant from the Spanish Rheumatology Foundation (FER) and laboratories KERN PHARMA for a brief stay abroad., Ana Pros Simón: None declared, Tarek Carlos Salman Monte: None declared, Manel Ciria: None declared, Francisco Vílchez-Oya: None declared, Selene Labrada: None declared, Toni Meraz: None declared, Jordi Monfort: None declared

A systematic review was conducted to analyze the tolerability of several oral iron supplements based on data obtained in available publications and to report the incidence of adverse effects (AEs) for each supplement both overall and gastrointestinal.Electronic databases - Medline, the Cochrane Library, and Embase were searched for studies published up to January 2009. Clinical or observational studies reporting data on the tolerability of oral iron supplements were included. Results were described statistically and a quasi-binomial logistic regression model was developed to evaluate and compare the tolerability of the supplements studied.For this review 111 studies were included, with data on 10,695 patients. Ferrous sulfate with mucoproteose had the lowest incidence of AEs (4.1% for overall AEs, 3.7% for gastrointestinal AEs [GAEs]) and was used as the reference supplement in the regression model. Incidence rates of overall AEs for the other supplements were 7.3% for iron protein succinylate [GAEs: 7%; OR for AE compared to the reference supplement, 1.96], 23.5% for ferrous glycine sulfate [GAEs: 18.5%; OR: 5.90], 30.9% for ferrous gluconate [GAEs: 29.9%; OR: 11.06], 32.3% for ferrous sulfate without mucoproteose [GAEs: 30.2%; OR: 11.21], and 47.0% for ferrous fumarate [GAEs: 43.4%; OR: 19.87]. The differences in incidence of AEs between extended-release ferrous sulfate with mucoproteose and all other supplements except iron protein succinylate were statistically significant at p0.001. These findings are subject to some limitations as the designs and methodologies of the studies included show heterogeneity among them that has partially been counteracted by the large sample size provided by the substantial number of trials, which is considered a strength in tolerability studies.Extended-release ferrous sulfate with mucoproteose appears to be the best tolerated of the different oral iron supplements evaluated.

Background and Objective: Calcium and vitamin D supplementation is recommended in patients with osteopenia and osteoporosis. One group that could benefit from this treatment is women with senile osteoporosis. Two sources of supplementary calcium are ossein-hydroxyapatite complex (OHC) and calcium carbonate, but, to date, their comparative effects on bone metabolism have not been studied in women with senile osteoporosis. The objective of this study was to compare the effects of OHC and calcium carbonate on bone metabolism in women with senile osteoporosis. Methods: This was a randomized, open-label, parallel-group, controlled, prospective study to compare the effects of OHC (treatment group) and calcium carbonate (control group) on bone metabolism. Patients were included between 2000 and 2004 and followed up for a maximum of 3 years. The study was carried out at the bone metabolism unit of two university hospitals in Barcelona, Spain. Subjects were women aged >65 years with densitometric osteoporosis of the lumbar spine or femoral neck. The treatment group received open-label OHC (Osteopor®) at a dose of two 830 mg tablets every 12 hours (712 mg elemental calcium per day). The control group received open-label calcium carbonate at a dose of 500 mg of elemental calcium every 12 hours (1000 mg elemental calcium per day). Both groups also received a vitamin D supplement (calcifediol 266 µg) at a dose of one vial orally every 15 days. Biochemical markers of bone remodelling (osteocalcin by electrochemiluminescence, tartrate-resistant acid phosphatase using colorimetry) were measured at baseline and annually for 3 years. Bone mineral density (BMD) at the lumbar spine and femoral neck was also measured. Results: One hundred and twenty women were included (55 in the OHC group and 65 in the calcium carbonate group), of whom 54 completed 3 years of follow-up. Levels of serum osteocalcin increased to a greater extent in the OHC group compared with the calcium carbonate group (by a mean ± SD of 0.84 ± 3.13 ng/mL at year 2 and 1.86 ±2.22 ng/mL at year 3 in the OHC group compared with a mean ± SD decrease of 0.39 ± 1.39 ng/mL at year 2 and an increase of 0.31 ± 2.51 ng/mL at year 3 in the calcium carbonate group); the differences between treatment groups were statistically significant (p

Objective Due to increasing improvement in the diagnosis, evaluation and management of osteoporosis and the development of new tools and drugs, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and other health professionals involved in the treatment of patients with osteoporosis. Methods Recommendations were developed following a nominal group methodology and based on a systematic review. The level of evidence and the degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. Evidence from previous consensus and available clinical guidelines was used. Results We have produced recommendations on diagnosis, evaluation and management of osteoporosis. These recommendations include the glucocorticoid-induced osteoporosis, premenopausal and male osteoporosis. Conclusions We present the SER recommendations related to the biologic therapy risk management.

Resumen Objetivo Dado el creciente avance en el diagnostico como evaluacion y tratamiento de la osteoporosis, y la incorporacion de nuevas herramientas y medicamentos, desde la Sociedad Espanola de Reumatologia (SER) se ha impulsado el desarrollo de recomendaciones basadas en la mejor evidencia posible. Estas deben de servir de referencia para reumatologos y otros profesionales de la salud implicados en el tratamiento de pacientes con osteoporosis. Metodos Las recomendaciones se emitieron siguiendo la metodologia de grupos nominales. El nivel de evidencia y el grado de recomendacion se clasificaron segun el modelo del Center for Evidence Based Medicine de Oxford y el grado de acuerdo se extrajo por tecnica Delphi. Se utilizo toda la informacion de consensos previos y guias de practica clinica disponibles. Resultados Se realizan recomendaciones sobre el diagnostico, la evaluacion y el tratamiento en pacientes con osteoporosis. Estas recomendaciones incluyen la osteoporosis secundaria a glucocorticoides, la osteoporosis premenopausica y la del varon. Conclusiones Se presentan las recomendaciones SER sobre el diagnostico, la evaluacion y el manejo de pacientes con osteoporosis.

Objective: There is increasing evidence to suggest that ossein-hydroxyapatite complex (OHC) is more effective than calcium supplements in maintaining bone mass. The aim of this meta-analysis was to determine whether OHC has a different clinical effect on bone mineral density (BMD) compared with calcium carbonate (CC). Methods: A meta-analysis of randomized controlled clinical trials was carried out to evaluate the efficacy of OHC versus CC on trabecular BMD. We identified publications on clinical trials by a search of electronic databases, including MEDLINE (1966-November 2008), EMBASE (1974-November 2008), and the Cochrane Controlled Clinical Trials Register. The primary endpoint was percent change in BMD from baseline. Data were pooled in a random-effects model, and the weighted mean difference was calculated. A sensitivity analysis that excluded trials without full data was performed. Results: Of the 18 controlled trials initially identified, 6 were included in the meta-analysis. There was no significant heterogeneity among the included trials. The percent change in BMD significantly favored the OHC group (1.02% [95% CI, 0.63-1.41], P < 0.00001). These results were confirmed in the sensitivity analysis. Conclusions: OHC is significantly more effective in preventing bone loss than CC.

LRP5 encodes the low-density lipoprotein receptor-related protein 5, a transmembrane protein involved in Wnt signaling. LRP5 is an important regulator of osteoblast growth and differentiation, affecting bone mass in vertebrates. Whether common variations in LRP5 are associated with normal BMD variation or osteoporotic phenotypes is of great relevance. We used a haplotype-based approach to search for common disease-associated variants in LRP5 in a cohort of 964 Spanish postmenopausal women. Twenty-four SNPs were selected, covering the LRP5 region, including the missense changes p.V667M and p.A1330V. The SNPs were genotyped and evaluated for association with BMD at the lumbar spine (LS) or femoral neck (FN) and with osteoporotic fracture, at single SNP and haplotype levels, by regression methods. Association with LS BMD was found for SNP 1, rs312009, located in the 5'-flanking region (p = 0.011, recessive model). SNP 6, rs2508836, in intron 1, was also associated with BMD, both at LS (p = 0.025, additive model) and FN (p = 0.031, recessive model). Two polymorphisms were associated with fracture: SNP 11, rs729635, in intron 1, and SNP 15, rs643892, in intron 5 (p = 0.007 additive model and p = 0.019 recessive model, respectively). Haplotype analyses did not provide additional information, except for haplotype "GC" of the block located at the 3'end of the gene. This haplotype spans intron 22 and the 3' untranslated region and was associated with FN BMD (p = 0.029, one copy of the haplotype versus none). In silico analyses showed that SNP 1 (rs312009) lies in a putative RUNX2 binding site. Electro-mobility shift assays confirmed RUNX2 binding to this site.

To evaluate the risk factors of new fractures after vertebroplasty (VP).Prospective, non-randomized study including patients with acute osteoporotic fractures treated with VP. Baseline visit included clinical and densitometric data. At 30, 90 and 180 days, changes in clinical data and side effects (cement leakage and new fractures) were recorded. To establish the predictive factors of a new fracture, differences between the group of patients with new fractures (R1) and those without fractures (R0) were evaluated.Vertebroplasty was performed in 43 patients (82 vertebrae). Cement leakage into a disc appeared in 11 cases (11,5%) and 12 new fractures occurred in 9 patients. No statistical differences were detected between groups R1 and R0 in the following variables: sex, age, vitamin D levels, T-score, kyphosis angle, primary/secondary osteoporosis, preexisting fractures, number of treated vertebrae and amount of cement injected. A positive, statistical significant correlation, was established between cement leakage into a disk and incidence of adjacent new fractures (p0.001).Cement leakage into a disc increases the risk of adjacent new fractures after vertebroplasty.

Stimulation of bone formation is a key therapeutic target in osteoporosis. Runx2 is a runt domain transcription factor essential to osteoblast differentiation, bone remodeling, and fracture healing. Runx2 knockout mice exhibit a complete lack of ossification, while overexpression of this gene in transgenic mice results in an osteoporotic phenotype. Thus, RUNX2 is a good candidate for the genetic determination of osteoporosis. In this association study, the effects of the -330 G/T polymorphism in promoter 1 and the -1025 T/C polymorphism (rs7771980) in promoter 2 of RUNX2 were tested in relation to lumbar spine (LS) and femoral neck (FN) bone mineral density (BMD) in a cohort of 821 Spanish postmenopausal women. The minor allele frequencies for the two polymorphisms were 0.15 and 0.07, respectively. The two polymorphisms, located more than 90 kb apart, were not in linkage disequilibrium (D' = 0.27, r (2) = 0.028). In an ANCOVA test adjusting by weight, height, age, and years since menopause, the -330 G/T polymorphism was not associated with any of the phenotypes analyzed, while we found the -1025 T/C polymorphism to be associated with FN BMD (p = 0.001). In particular, individuals carrying the TC genotype had higher mean adjusted FN BMD values than those bearing the TT genotype. Our results highlight the importance of this RUNX2 promoter 2 polymorphism in FN BMD determination.

Javier Haya-Palazuelos1, Camil Castelo-Branco2,3, Maria J. Cancelo-Hidalgo4,5, Santiago Palacios6, Manel Ciria-Recasens7, Antonio Fernandez-Pareja8, Jose Manasanch-Dalmau9,∗ 1 Hospital General Universitario de Ciudad Real, Ciudad Real, Spain 2 Institut Clinic of Gynecology, Obstetrics and Neonatology, Hospital Clinic, Barcelona, Spain 3 Institut dInvestigacions Biomediques August Pi i Sunyer (IDIBAPS), Faculty of Medicine University of Barcelona, Barcelona, Spain 4 Hospital Universitario de Guadalajara, Guadalajara, Spain 5 Universidad de Alcala, Alcala de Henares, Spain 6 Palacios Institute of Woman’s Health, Madrid, Spain 7 Reumatology Department Parc de Salut Mar. Hospital Universitari del Mar, Barcelona, Spain 8 CMS Hortaleza, Madrid, Spain 9 Pierre Fabre Iberica, Barcelona, Spain