Assessment of Denosumab in Korean Postmenopausal Women with Osteoporosis: Randomized, Double-Blind, Placebo-Controlled Trial with Open-Label Extension
Yonsei Medical Journal
;
: 905-914, 2016.
Article
in English
| WPRIM
| ID: wpr-63333
ABSTRACT
PURPOSE:
The efficacy and safety of denosumab was compared with placebo in Korean postmenopausal women with osteoporosis in this phase III study. MATERIALS ANDMETHODS:
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Bone Density
/
Osteoporosis, Postmenopausal
/
Double-Blind Method
/
Postmenopause
/
Asian People
/
Bone Density Conservation Agents
/
Femur
/
Femur Neck
/
Republic of Korea
/
Denosumab
Type of study:
Controlled clinical trial
Limits:
Aged
/
Aged80
/
Female
/
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Yonsei Medical Journal
Year:
2016
Type:
Article
Similar
MEDLINE
...
LILACS
LIS