Assessment of Denosumab in Korean Postmenopausal Women with Osteoporosis: Randomized, Double-Blind, Placebo-Controlled Trial with Open-Label Extension.
10.3349/ymj.2016.57.4.905
- Author:
Jung Min KOH
1
;
Dong Jin CHUNG
;
Yoon Sok CHUNG
;
Moo Il KANG
;
In Ju KIM
;
Yong Ki MIN
;
Han Jin OH
;
Il Hyung PARK
;
Yil Seob LEE
;
Barbara KRAVITZ
;
Brian WATERHOUSE
;
Antonio NINO
;
Lorraine A FITZPATRICK
Author Information
1. Division of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
- Publication Type:Clinical Trial, Phase III ; Original Article ; Randomized Controlled Trial
- Keywords:
Denosumab;
postmenopausal osteoporosis;
Korea;
bone mineral density;
biochemical markers of bone turnover
- MeSH:
Aged;
Aged, 80 and over;
*Asian Continental Ancestry Group;
Bone Density;
Bone Density Conservation Agents/*therapeutic use;
Denosumab/*therapeutic use;
Double-Blind Method;
Female;
Femur;
Femur Neck;
Humans;
Lumbar Vertebrae;
Middle Aged;
Osteoporosis, Postmenopausal/*drug therapy/*ethnology;
Postmenopause;
Republic of Korea
- From:Yonsei Medical Journal
2016;57(4):905-914
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: The efficacy and safety of denosumab was compared with placebo in Korean postmenopausal women with osteoporosis in this phase III study. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
