Efficacy of denosumab co-administered with vitamin D and Ca by baseline vitamin D status
| Autor: | Toshitaka Nakamura, Naoki Okubo, Hideo Takami, Toshio Matsumoto, Takayuki Hosoi, Toshitsugu Sugimoto, Makiko Kobayashi, Masataka Shiraki |
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| Rok vydání: | 2020 |
| Předmět: |
Male
0301 basic medicine medicine.medical_specialty Drug trial Endocrinology Diabetes and Metabolism chemistry.chemical_element 030209 endocrinology & metabolism Calcium Lower risk Placebo Placebo group Gastroenterology 03 medical and health sciences 0302 clinical medicine Endocrinology Double-Blind Method Bone Density Internal medicine Vitamin D and neurology medicine Humans Orthopedics and Sports Medicine Vitamin D Aged Bone Density Conservation Agents business.industry General Medicine Treatment Outcome Denosumab chemistry Spinal Fractures Female Primary osteoporosis 030101 anatomy & morphology business medicine.drug |
| Zdroj: | Journal of Bone and Mineral Metabolism. 38:848-858 |
| ISSN: | 1435-5604 0914-8779 |
| Popis: | In anti-osteoporosis drug trials, vitamin D and calcium (Ca) are common supplements; however, the optimal dose of each is unclear. Using data from the randomized, double-blind, placebo-controlled DIRECT trial, we assessed whether baseline serum 25-hydroxy vitamin D (25[OH]D) level influences the efficacy of denosumab co-administered with vitamin D and Ca.In this prespecified sub-analysis, subjects with primary osteoporosis who received denosumab or placebo, plus vitamin D (≥ 400 IU/day) and Ca (≥ 600 mg/day), were classified as 25(OH)D deficient ( 20 ng/mL), insufficient (≥ 20 to 30 ng/mL), and sufficient (≥ 30 ng/mL). Study endpoints included absolute serum 25(OH)D level at baseline, 12 months, and 24 months; change in serum 25(OH)D and bone mineral density (BMD) status from baseline; and incidence of new vertebral fractures at 24 months.In 475 denosumab-treated and 481 placebo-treated subjects, proportions with deficient/insufficient/sufficient 25(OH)D at baseline were 53.1%/37.1%/9.9% and 50.9%/42.0%/7.1%, respectively. Supplementation significantly increased mean serum 25(OH)D levels; at 24 months, mean levels were 30 ng/mL (sufficient) in both treatment groups. Increase in BMD over time was higher in the denosumab group vs. placebo group in all three vitamin D status groups. At month 24, denosumab-treated subjects with deficient/insufficient baseline 25(OH)D had a significantly lower risk of new vertebral fracture vs. placebo-treated subjects.Among DIRECT trial subjects supplemented with ≥ 400 IU/day of vitamin D and ≥ 600 mg/day of Ca, baseline 25(OH)D sufficiency may not influence the efficacy of denosumab in increasing BMD or preventing vertebral fractures. |
| Databáze: | OpenAIRE |
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