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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
67
Administered by subcutaneous injection once a month (QM)
Administered by subcutaneous injections once a month
Research Site
Busan, South Korea
Research Site
Gwangju, South Korea
Research Site
Namdong-gu, Incheon, South Korea
Research Site
Seongnam Si Gyeonggi Do, South Korea
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine
Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Time frame: Baseline and month 6
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip
Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Time frame: Baseline and month 6
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck
Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Time frame: Baseline and month 6
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Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Suwon-si, Gyeonggi-do, South Korea