Study Complete
Sponsor ID
20040132

Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Sponsor ID
20040132
Clinicaltrials.gov ID
NCT00091793
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
332
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent Change from Baseline in Lumbar Spine Bone Mineral Density at Month 24

Timeframe: Baseline and 24 Months

Secondary Outcome Measures

Percent Change from Baseline in Total Hip Bone Mineral Density at Month 24

Timeframe: Baseline and 24 Months

Percent Change from Baseline in Femoral Neck Bone Mineral Density at Month 24

Timeframe: Baseline and 24 Months

Percent Change from Baseline in Trochanter Bone Mineral Density at Month 24

Timeframe: Baseline and 24 months

Percent Change from Baseline in Distal 1/3 Radius Bone Mineral Density at Month 24

Timeframe: Baseline and 24 months

Percent Change from Baseline in Total Body (without head) Bone Mineral Density at Month 24

Timeframe: Baseline and 24 months

Percent Change from Baseline in Distal Radius Trabecular Volumetric Bone Mineral Density at Month 24

Timeframe: Baseline and 24 months

Percent Change from Baseline in Distal Radius Cortical Volumetric Bone Mineral Density at Month 24

Timeframe: Baseline and 24 months

Percent Change from Baseline in Distal Radius Total Volumetric Bone Mineral Density at Month 24

Timeframe: Baseline and 24 months

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.