Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: AMG 162 (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
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.
Clinical Details
Official title: A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
Secondary outcome: Total Hip Bone Mineral Density Percent Change From Baseline at Month 24Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Trochanter Bone Mineral Density Percent Change From Baseline at Month 24 Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24 Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24 Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Eligibility
Minimum age: N/A.
Maximum age: 90 Years.
Gender(s): Female.
Criteria:
Eligibility Criteria
- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between
1. 0 and - 2. 5)
Locations and Contacts
Additional Information
AmgenTrials clinical trials website Notice regarding posted summaries of trial results
Starting date: August 2004
Last updated: December 22, 2010
|