Study Complete
Sponsor ID
20150242
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women with Osteoporosis
Study Details
The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.
Protocol Summary
Primary Outcome Measures
Change from baseline in bone mineral density at the lumbar spine at 6 months.
Timeframe: 6 months
Secondary Outcome Measures
Change from baseline in bone mineral density at the total hip at 6 months.
Timeframe: 6 months
Change from baseline in bone mineral density at the femoral neck at 6 months.
Timeframe: 6 months
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Seoul, Republic of Korea, 138-736
Status
Recruiting
Location
Research Site
Busan, Republic of Korea, 602-739
Status
Recruiting
Location
Research Site
Suwon-si, Gyeonggi-do, Republic of Korea, 443-380
Status
Recruiting
Location
Research Site
Namdong-gu, Incheon, Republic of Korea, 21565
Status
Recruiting
Location
Research Site
Gwangju, Republic of Korea, 501-757
Status
Recruiting
Location
Research Site
Seongnam si Gyeonggi do, Republic of Korea, 463-707
Status
Recruiting