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Dose Response Study of Denosumab in Japanese Postmenopausal Osteoporosis
NCT00306189Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2006
- Primary completion
- Jun 2007
- Sponsor
- Amgen
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- denosumab
- Conditions
- osteoporosis
01
Overview
Phase 2, randomised, double-blind trial of denosumab in osteoporosis (4 arms), sponsored by Amgen. Primary endpoint: Lumbar Spine Bone Mineral Density Percent Change From Baseline at 12 months. Started Jan 2006; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
100 mg AMG 162
100 mg Denosumab SC every 6 months
60 mg AMG 162
60 mg Denosumab SC every 6 months
14 mg AMG 162
14 mg Denosumab SC every 6 months
Placebo
Placebo SC every 6 months
03
Who it enrols
Ambulatory postmenopausal women with specific low BMD values at the lumbar spine, femoral neck, and total hip, excluding those with recent bisphosphonate or PTH use.
04
Endpoints
Primary
Lumbar Spine Bone Mineral Density Percent Change From Baseline
Secondary
Total Hip Bone Mineral Density Percent Change From Baseline
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline
Serum CTX, Urinary NTX/Cr, Bone Alkaline Phosphatase
05
Results
Primary endpoints met
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