Phase 3
Completed N=67
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
Source: ClinicalTrials.gov NCT02791516 ↗Enrolled (actual)
67
Serious AEs
3.0%
Results posted
Jul 2019
Primary outcomePrimary: Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine — -0.1; 9.5 percent change — p=<0.001
◆ Published Evidence
Established
28citations · ~6 / year
Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study.
Summary
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.
Linked Publications
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Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine |
-0.1; 9.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip |
0.3; 2.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck |
0.8; 3.0 | 0.004 sig |
Eligibility Criteria
Inclusion Criteria
- Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.
- Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening.
- BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck.
- At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA.
- Other inclusion criteria may apply.
Exclusion Criteria
- Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck.
- History of hip fracture.
- Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities.
- Known sensitivity or intolerance calcium and vitamin D products.
- Other exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02791516) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.