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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 24

Femoral 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

Page last updated: August 23, 2015

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