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Clinical Trials Express: Fracture Risk Reduction With Denosumab in Japanese Postmenopausal Women and Men With Osteoporosis: Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT)

The journal of clinical endocrinology and metabolism, 2014-07, Vol.99 (7), p.2599-2607 [Tạp chí có phản biện]

Copyright © 2014 by the Endocrine Society ;Copyright © 2014 by the Endocrine Society 2014 ;ISSN: 0021-972X ;EISSN: 1945-7197 ;DOI: 10.1210/jc.2013-4175 ;PMID: 24646104

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Nhan đề:
Clinical Trials Express: Fracture Risk Reduction With Denosumab in Japanese Postmenopausal Women and Men With Osteoporosis: Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT)
Tác giả: Nakamura, Toshitaka ; Matsumoto, Toshio ; Sugimoto, Toshitsugu ; Hosoi, Takayuki ; Miki, Takami ; Gorai, Itsuo ; Yoshikawa, Hideki ; Tanaka, Yoshiya ; Tanaka, Sakae ; Sone, Teruki ; Nakano, Tetsuo ; Ito, Masako ; Matsui, Shigeyuki ; Yoneda, Toshiyuki ; Takami, Hideo ; Watanabe, Ko ; Osakabe, Taisuke ; Shiraki, Masataka ; Fukunaga, Masao
Chủ đề: Aged ; Aged, 80 and over ; Alendronate - therapeutic use ; Antibodies, Monoclonal, Humanized - therapeutic use ; Denosumab ; Endocrine Research ; Female ; Humans ; Japan - epidemiology ; Male ; Middle Aged ; Osteoporosis - drug therapy ; Osteoporosis - epidemiology ; Osteoporosis, Postmenopausal - drug therapy ; Osteoporosis, Postmenopausal - epidemiology ; Osteoporotic Fractures - epidemiology ; Osteoporotic Fractures - etiology ; Osteoporotic Fractures - prevention & control ; Placebos ; Risk Factors ; Treatment Outcome
Là 1 phần của: The journal of clinical endocrinology and metabolism, 2014-07, Vol.99 (7), p.2599-2607
Mô tả: Context: Denosumab 60 mg sc injection every 6 months for 36 months was well tolerated and effective in reducing the incidence of vertebral, nonvertebral, and hip fracture in predominantly Caucasian postmenopausal women with osteoporosis. Objective: The objective of this phase 3 fracture study was to examine the antifracture efficacy and safety of denosumab 60 mg in Japanese women and men with osteoporosis compared with placebo. Design and Setting: A randomized, double-blind, placebo-controlled trial with an open-label active comparator as a referential arm was conducted. Patients: Subjects were 1262 Japanese patients with osteoporosis aged 50 years or older, who had one to four prevalent vertebral fractures. Intervention: Subjects were randomly assigned to receive denosumab 60 mg sc every 6 months (n = 500), placebo for denosumab (n = 511), or oral alendronate 35 mg weekly (n = 251). All subjects received daily supplements of calcium and vitamin D. Main Outcome Measure: The primary endpoint was the 24-month incidence of new or worsening vertebral fracture for denosumab vs placebo. Results: Denosumab significantly reduced the risk of new or worsening vertebral fracture by 65.7%, with incidences of 3.6% in denosumab and 10.3% in placebo at 24 months (hazard ratio 0.343; 95% confidence interval 0.194–0.606, P = .0001). No apparent difference in adverse events was found between denosumab and placebo during the first 24 months of the study. Conclusion: These results provide evidence of the efficacy and safety of denosumab 60 mg sc every 6 months in Japanese subjects with osteoporosis.
Nơi xuất bản: United States: Endocrine Society
Ngôn ngữ: English
Số nhận dạng: ISSN: 0021-972X
EISSN: 1945-7197
DOI: 10.1210/jc.2013-4175
PMID: 24646104
Nguồn: Geneva Foundation Free Medical Journals at publisher websites
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Clinical Trials Express: Fracture Risk Reduction With Denosumab in Japanese Postmenopausal Women and Men With Osteoporosis: Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT)

Copyright © 2014 by the Endocrine Society ;Copyright © 2014 by the Endocrine Society 2014 ;ISSN: 0021-972X ;EISSN: 1945-7197 ;DOI: 10.1210/jc.2013-4175 ;PMID: 24646104

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