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AMG 162 for Bone Loss in Prostate Cancer Patients on ADT
NCT00089674Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2004
- Primary completion
- May 2008
- Sponsor
- Amgen
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- denosumab
- Conditions
- osteoporosis
01
Overview
Phase 3, randomised, double-blind trial in osteoporosis comparing AMG 162 with Placebo (2 arms). Primary endpoint: Lumbar Spine Bone Mineral Density Percent Change From Baseline at 24 months. Started Aug 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
AMG 162
Denosumab 60 mg SC every 6 months
Placebo
Placebo SC every 6 months
03
Who it enrols
Men with non-metastatic prostate cancer undergoing androgen-deprivation therapy (ADT). Patients must be at risk for fracture (e.g., age >70 or low BMD).
04
Endpoints
Primary
Lumbar Spine Bone Mineral Density Percent Change From Baseline
Secondary
Femoral Neck Bone Mineral Density Percent Change From Baseline
Total Hip Bone Mineral Density Percent Change From Baseline
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36
Number of Participants With Any Fracture
Number of Participants With a New Vertebral Fracture
Time to First Clinical Fracture
05
Results
Primary endpoints met
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