Assessment of Denosumab in Korean Postmenopausal Women with Osteoporosis: Randomized, Double-Blind, Placebo-Controlled Trial with Open-Label Extension

• Published in: Yonsei medical journal Vol. 57; no. 4; pp. 905 - 914
• Main Authors: Koh, Jung-Min, Chung, Dong Jin, Chung, Yoon-Sok, Kang, Moo-Il, Kim, In-Ju, Min, Yong-Ki, Oh, Han-Jin, Park, Il Hyung, Lee, Yil-Seob, Kravitz, Barbara, Waterhouse, Brian, Nino, Antonio, Fitzpatrick, Lorraine A.
• Format: Journal Article
• Language: English
• Published: Korea (South) Yonsei University College of Medicine 01.07.2016; 연세대학교의과대학
• Subjects: Aged; Aged, 80 and over; Asian People; Bone Density; Bone Density Conservation Agents - therapeutic use; Denosumab - therapeutic use; Double-Blind Method; Female; Femur; Femur Neck; Humans; Lumbar Vertebrae; Middle Aged; Original; Osteoporosis, Postmenopausal - drug therapy; Osteoporosis, Postmenopausal - ethnology; Postmenopause; Republic of Korea; 의학일반; Republic of Korea; biochemical markers of bone turnover; bone mineral density; Denosumab; postmenopausal osteoporosis; Korea
• ISSN: 0513-5796; 1976-2437
• DOI: 10.3349/ymj.2016.57.4.905

The efficacy and safety of denosumab was compared with placebo in Korean postmenopausal women with osteoporosis in this phase III study. Women aged 60 to 90 years with a T-score of <-2.5 and ≥-4.0 at the lumbar spine or total hip were randomized to a single 60 mg subcutaneous dose of denosumab or placebo for the 6-month double-blind phase. Eligible subjects entered the 6-month open-label extension phase and received a single dose of denosumab 60 mg. Baseline demographics were similar in the 62 denosumab- and 64 placebo-treated subjects who completed the double-blind phase. Treatment favored denosumab over placebo for the primary endpoint {mean percent change from baseline in lumbar spine bone mineral density (BMD) at Month 6 [3.2% (95% confidence interval 2.1%, 4.4%; p<0.0001)]}; and secondary endpoints (mean percent change from baseline in lumbar spine BMD at Month 1, total hip, femoral neck, and trochanter BMD at Months 1 and 6, and median percent change from baseline in bone turnover markers at Months 1, 3, and 6). Endpoint improvements were sustained over 12 months in the open-label extension (n=119). There were no new or unexpected safety signals. Denosumab was well tolerated and effective in increasing BMD and decreasing bone turnover markers over a 12-month period in Korean postmenopausal women. The findings of this study demonstrate that denosumab has beneficial effects on the measures of osteoporosis in Korean postmenopausal women.