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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).

Author(s): Nakamura T(1), Matsumoto T, Sugimoto T, Hosoi T, Miki T, Gorai I, Yoshikawa H, Tanaka Y, Tanaka S, Sone T, Nakano T, Ito M, Matsui S, Yoneda T, Takami H, Watanabe K, Osakabe T, Shiraki M, Fukunaga M.

Affiliation(s): Author information: (1)National Center for Global Health and Medicine (T.Nakam.), Tokyo 162-8655, Japan; Department of Medicine and Bioregulatory Sciences (T.Matsu.), University of Tokushima Graduate School of Medical Sciences, Tokushima 770-8503, Japan; Internal Medicine 1 (T.Su.), Shimane University Faculty of Medicine, Izumo 693-8501, Japan; Kenkoin Clinic (T.H.), Tokyo 104-0061, Japan; Department of Geriatric (T.Mi.), Osaka City University Medical School, Osaka 545-8585, Japan; Hori Hospital (I.G.), Yokohama 246-0021, Japan; Department of Orthopedic Surgery (H.Y.), Osaka University Graduate School of Medicine, Suita 565-0871, Japan; The First Department of Internal Medicine (Y.T.), University of Occupational and Environmental Health, Kitakyushu 807-8555, Japan; Department of Orthopaedic Surgery Faculty of Medicine (S.T.), The University of Tokyo, Tokyo 113-8655, Japan; Department of Nuclear Medicine (T.So.), Kawasaki Medical School (M.F.), Kurashiki 701-0192, Japan; Tamana Central Hospital (T.Nakan.), Tamana 865-0064, Japan; Division of Radiology (M.I.), Nagasaki University School of Medicine, Nagasaki 852-8501, Japan; Department of Biostatistics (S.M.), Nagoya University Graduate School of Medicine, Nagoya 466-8550, Japan; Osaka University Graduate School of Dentistry (T.Y.), Suita 565-0871, Japan; Daiichi Sankyo Co Ltd (H.T., K.W., T.O.), Tokyo 140-8710, Japan; and Research Institute and Practice for Involutional Diseases (M.S.), Azumino 399-8101, Japan.

Publication date & source: 2014, J Clin Endocrinol Metab. , 99(7):2599-607

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.

Page last updated: 2014-11-30

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