Phase 3
Completed N=332
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Source: ClinicalTrials.gov NCT00091793 ↗Enrolled (actual)
332
Serious AEs
8.2%
Results posted
Jan 2010
Primary outcomePrimary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 — 6.5; -.6 Percent Change from Baseline — p=<0.0001
Summary
This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 |
6.5; -.6 | <0.0001 sig |
| SECONDARY Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 |
3.4; -1.1 | — |
| SECONDARY Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 |
2.8; -.9 | — |
| SECONDARY Trochanter Bone Mineral Density Percent Change From Baseline at Month 24 |
5.2; -.8 | — |
| SECONDARY Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24 |
1.4; -2.1 | — |
| SECONDARY Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24 |
2.4; -1.4 | — |
| SECONDARY Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 |
8.7; -.7 | — |
| SECONDARY Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 |
.3; -1.4 | — |
| SECONDARY Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 |
.8; -1.9 | — |
Eligibility Criteria
Eligibility Criteria
- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)
Data sourced from ClinicalTrials.gov (NCT00091793). 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.