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      La suplementación de calcio y vitamina D en el manejo de la osteoporosis. ¿Cuál es la dosis aconsejable de vitamina D? Translated title: Calcium and vitamin D supplementation in the management of osteoporosis. What is the advisable dose of vitamin D?

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          Abstract

          Resumen Los fundamentos fisiopatológicos que justifican la suplementación con calcio y vitamina D en la osteoporosis se sustancian en una amplia evidencia científica que se ha obtenido a través de varios ensayos clínicos aleatorizados y posteriores meta-análisis que han demostrado una reducción del riesgo de fracturas osteoporóticas estadísticamente significativa y clínicamente relevante. Esta evidencia ha conducido a su recomendación por parte de varias sociedades científicas interesadas en el manejo de la osteoporosis. Con el fin de optimizar la eficacia y el balance beneficio/riesgo de estos, el calcio y la vitamina D deben administrarse conjuntamente con los fármacos que se prescriban para el tratamiento de la osteoporosis, pues en todos estos estudios de referencia se ha utilizado calcio y vitamina D tanto en la rama que recibe el fármaco como la del placebo. La sal de calcio mayormente utilizada es el carbonato y el metabolito de la vitamina D, el colecalciferol o vitamina D3. No existe consenso ni evidencia científica concluyente sobre cuál es la dosis a emplear en la deficiencia de vitamina D asociada a osteoporosis. No obstante, la tendencia ha sido siempre a ir aumentando estas cantidades, desde las 400 UI que se recomendaban hace unos 30 años a las 2.000 UI diarias de la actualidad. Revisaremos en este artículo cuales son las recomendaciones que se realizan por medio de las guías clínicas, al recoger éstas la evidencia científica disponible.

          Translated abstract

          Summary The pathophysiological foundations justifying calcium and vitamin D supplements in osteoporosis are supported by extensive scientific evidence that has been obtained through several randomized clinical trials and subsequent meta-analyzes that have shown a statistically significant and clinically relevant reduction in the risk of osteoporotic fractures. This evidence has led to its recommendation by several scientific societies interested in the management of osteoporosis. In order to optimize the efficacy and the benefit/risk balance of these, calcium and vitamin D should be administered together with the drugs that are prescribed for the treatment of osteoporosis, since calcium and vitamin D have been used in all these reference studies, both in the arm that receives the drug and also in the placebo arm. The most commonly used calcium salt is carbonate and the metabolite of vitamin D, cholecalciferol or vitamin D3. There is no consensus or conclusive scientific evidence on the dose to be used in vitamin D deficiency associated with osteoporosis. However, the trend has always been to increase these amounts, from the 400 IU recommended 30 years ago to the 2,000 IU daily today. We will review in this article which recommendations are made by means of the clinical guidelines, as they collect the available scientific evidence.

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          Most cited references45

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          Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.

          Once-daily injections of parathyroid hormone or its amino-terminal fragments increase bone formation and bone mass without causing hypercalcemia, but their effects on fractures are unknown. We randomly assigned 1637 postmenopausal women with prior vertebral fractures to receive 20 or 40 microg of parathyroid hormone (1-34) or placebo, administered subcutaneously by the women daily. We obtained vertebral radiographs at base line and at the end of the study (median duration of observation, 21 months) and performed serial measurements of bone mass by dual-energy x-ray absorptiometry. New vertebral fractures occurred in 14 percent of the women in the placebo group and in 5 percent and 4 percent, respectively, of the women in the 20-microg and 40-microg parathyroid hormone groups; the respective relative risks of fracture in the 20-microg and 40-microg groups, as compared with the placebo group, were 0.35 and 0.31 (95 percent confidence intervals, 0.22 to 0.55 and 0.19 to 0.50). New nonvertebral fragility fractures occurred in 6 percent of the women in the placebo group and in 3 percent of those in each parathyroid hormone group (relative risk, 0.47 and 0.46, respectively [95 percent confidence intervals, 0.25 to 0.88 and 0.25 to 0.861). As compared with placebo, the 20-microg and 40-microg doses of parathyroid hormone increased bone mineral density by 9 and 13 more percentage points in the lumbar spine and by 3 and 6 more percentage points in the femoral neck; the 40-microg dose decreased bone mineral density at the shaft of the radius by 2 more percentage points. Both doses increased total-body bone mineral by 2 to 4 more percentage points than did placebo. Parathyroid hormone had only minor side effects (occasional nausea and headache). Treatment of postmenopausal osteoporosis with parathyroid hormone (1-34) decreases the risk of vertebral and nonvertebral fractures; increases vertebral, femoral, and total-body bone mineral density; and is well tolerated. The 40-microg dose increased bone mineral density more than the 20-microg dose but had similar effects on the risk of fracture and was more likely to have side effects.
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            Clinician’s Guide to Prevention and Treatment of Osteoporosis

            The Clinician’s Guide to Prevention and Treatment of Osteoporosis was developed by an expert committee of the National Osteoporosis Foundation (NOF) in collaboration with a multispecialty council of medical experts in the field of bone health convened by NOF. Readers are urged to consult current prescribing information on any drug, device, or procedure discussed in this publication.
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              Denosumab for prevention of fractures in postmenopausal women with osteoporosis.

              Denosumab is a fully human monoclonal antibody to the receptor activator of nuclear factor-kappaB ligand (RANKL) that blocks its binding to RANK, inhibiting the development and activity of osteoclasts, decreasing bone resorption, and increasing bone density. Given its unique actions, denosumab may be useful in the treatment of osteoporosis. We enrolled 7868 women between the ages of 60 and 90 years who had a bone mineral density T score of less than -2.5 but not less than -4.0 at the lumbar spine or total hip. Subjects were randomly assigned to receive either 60 mg of denosumab or placebo subcutaneously every 6 months for 36 months. The primary end point was new vertebral fracture. Secondary end points included nonvertebral and hip fractures. As compared with placebo, denosumab reduced the risk of new radiographic vertebral fracture, with a cumulative incidence of 2.3% in the denosumab group, versus 7.2% in the placebo group (risk ratio, 0.32; 95% confidence interval [CI], 0.26 to 0.41; P<0.001)--a relative decrease of 68%. Denosumab reduced the risk of hip fracture, with a cumulative incidence of 0.7% in the denosumab group, versus 1.2% in the placebo group (hazard ratio, 0.60; 95% CI, 0.37 to 0.97; P=0.04)--a relative decrease of 40%. Denosumab also reduced the risk of nonvertebral fracture, with a cumulative incidence of 6.5% in the denosumab group, versus 8.0% in the placebo group (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01)--a relative decrease of 20%. There was no increase in the risk of cancer, infection, cardiovascular disease, delayed fracture healing, or hypocalcemia, and there were no cases of osteonecrosis of the jaw and no adverse reactions to the injection of denosumab. Denosumab given subcutaneously twice yearly for 36 months was associated with a reduction in the risk of vertebral, nonvertebral, and hip fractures in women with osteoporosis. (ClinicalTrials.gov number, NCT00089791.) 2009 Massachusetts Medical Society
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                Author and article information

                Journal
                romm
                Revista de Osteoporosis y Metabolismo Mineral
                Rev Osteoporos Metab Miner
                Sociedad Española de Investigaciones Óseas y Metabolismo Mineral (Madrid, Madrid, Spain )
                1889-836X
                2173-2345
                June 2021
                : 13
                : 2
                : 77-83
                Affiliations
                [02] Las Palmas de Gran Canaria orgnameHospital Universitario Insular orgdiv1Unidad Metabólica Ósea España
                [03] Sevilla Andalucía orgnameUniversidad de Sevilla orgdiv1Departamento de Medicina Spain
                [01] Las Palmas de Gran Canaria orgnameUniversidad de Las Palmas de Gran Canaria orgdiv1Grupo de Investigación en Osteoporosis y Metabolismo Mineral Óseo Spain
                Article
                S1889-836X2021000200006 S1889-836X(21)01300200006
                10.4321/s1889-836x2021000200006
                54561c7f-17fe-4a28-837a-a520edc36c05

                This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 International License.

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