Consenso Delphi sobre Estrategias Terapéuticas y de Prevención Sanitaria de la hipovitaminosis D / Delphi Consensus on Therapeutic and Preventive Health Strategies for Hypovitaminosis D

Antecedentes: La elevada prevalencia de hipovitaminosis D en España es considerada una verdadera epidemia con importantes implicaciones para la salud por las múltiples funciones que ejerce la vitamina D tanto a nivel esquelético como extraesquelético. Para que las personas con insuficiencia o deficiencia en vitamina D alcancen los niveles séricos más adecuados, deben recibir suplementos de vitamina D. Este estudio se realizó con la finalidad de evaluar si en la práctica clínica habitual, el manejo de la hipovitaminosis D era llevada a cabo según las recomendaciones internacionales establecidas por las sociedades científicas.Métodos: Se realizaron dos rondas de circulación de un cuestionario Delphi entre un panel formado por médicos prescriptores habituales de vitamina D.Resultados: En general, los médicos del panel reconocieron la alta prevalencia de la hipovitaminosis D en España, la necesidad del cribado en los distintos grupos de riesgo y los beneficios de la suplementación en los pacientes con insuficiencia o déficit de vitamina D. Sin embargo, no se alcanzó el consenso en algunas de las aseveraciones relacionadas con los métodos de cuantificación de la vitamina D o con las recomendaciones para el manejo de la hipovitaminosis D.Conclusiones: La ausencia de acuerdo para algunos de los ítems reveló la necesidad de realizar acciones formativas destinadas a proporcionar un conocimiento adecuado y actualizado sobre las evidencias científicas y las recomendaciones para la práctica clínica de la suplementación de vitamina D. (AU)

Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates.

Transitioning postmenopausal women with osteoporosis from a bisphosphonate to denosumab appears to be safe and more effective at improving BMD than continuing treatment with a bisphosphonate. INTRODUCTION: We conducted a patient-level pooled analysis of four studies to estimate the efficacy and safety of transitioning to denosumab vs. continuing bisphosphonate treatment in postmenopausal women who previously received oral bisphosphonates. METHODS: Patients received 60 mg denosumab once every 6 months or a bisphosphonate (oral alendronate, risedronate, ibandronate, or intravenous zoledronic acid). Endpoints were change from baseline in lumbar spine, total hip, femoral neck, and 1/3 radius BMD at month 12, change from baseline in serum CTX-1 and P1NP, and incidence of adverse events. RESULTS: A total of 2850 randomized patients (1424 bisphosphonate:1426 denosumab) were included in the analysis. Percentage change in BMD was significantly greater (p < 0.001) for denosumab vs. bisphosphonate at each skeletal site; differences in BMD changes ranged from 0.6 to 2.0%. Percentage decrease in serum CTX-1 and P1NP was significantly greater (p < 0.0001) for denosumab vs. bisphosphonate at months 1, 6, and 12; in the denosumab group only, percentage change in serum CTX-1 at month 1 was significantly correlated with percentage change in lumbar spine and total hip BMD at month 12. The incidences of adverse events were similar between treatment groups. Three patients (one bisphosphonate and two denosumab) had atypical femoral fractures, all from the denosumab vs. zoledronic acid study. CONCLUSION: Postmenopausal women can safely transition from a bisphosphonate to denosumab, which is more effective at improving BMD than continuing with a bisphosphonate. CLINICAL TRIALS REGISTRATION: NCT00377819, NCT00919711, NCT00936897, NCT01732770.

Relationship Between Bone Mineral Density T-Score and Nonvertebral Fracture Risk Over 10 Years of Denosumab Treatment.

Although treat-to-target strategies are being discussed in osteoporosis, there is little evidence of what the target should be to reduce fracture risk maximally. We investigated the relationship between total hip BMD T-score and the incidence of nonvertebral fracture in women who received up to 10 years of continued denosumab therapy in the FREEDOM (3 years) study and its long-term Extension (up to 7 years) study. We report the percentages of women who achieved a range of T-scores at the total hip or femoral neck over 10 years of denosumab treatment (1343 women completed 10 years of treatment). The incidence of nonvertebral fractures was lower with higher total hip T-score. This relationship plateaued at a T-score between -2.0 and -1.5 and was independent of age and prevalent vertebral fractures, similar to observations in treatment-naïve subjects. Reaching a specific T-score during denosumab treatment was dependent on the baseline T-score, with higher T-scores at baseline more likely to result in higher T-scores at each time point during the study. Our findings highlight the importance of follow-up BMD measurements in patients receiving denosumab therapy because BMD remains a robust indicator of fracture risk. These data support the notion of a specific T-score threshold as a practical target for therapy in osteoporosis. © 2019 The Authors Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR).