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- Title
Clinical Trials Express: fracture risk reduction with denosumab in Japanese postmenopausal women and men with osteoporosis: denosumab fracture intervention randomized placebo controlled trial (DIRECT).
- Authors
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
- Abstract
<bold>Context: </bold>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.<bold>Objective: </bold>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.<bold>Design and Setting: </bold>A randomized, double-blind, placebo-controlled trial with an open-label active comparator as a referential arm was conducted.<bold>Patients: </bold>Subjects were 1262 Japanese patients with osteoporosis aged 50 years or older, who had one to four prevalent vertebral fractures.<bold>Intervention: </bold>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.<bold>Main Outcome Measure: </bold>The primary endpoint was the 24-month incidence of new or worsening vertebral fracture for denosumab vs placebo.<bold>Results: </bold>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.<bold>Conclusion: </bold>These results provide evidence of the efficacy and safety of denosumab 60 mg sc every 6 months in Japanese subjects with osteoporosis.
- Publication
Journal of Clinical Endocrinology & Metabolism, 2014, Vol 99, Issue 7, p2599
- ISSN
0021-972X
- Publication type
journal article
- DOI
10.1210/jc.2013-4175