A Randomized, Double-Blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Postmenopausal Women With Low Bone Mineral Density
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 412
- Primary Endpoint
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms
Study Overview
Brief Summary
To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 80 Years (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
Intervention: Placebo (Drug)
Denosumab 60 mg every 6 months
Participants received denosumab 60 mg SC every 6 months until Month 42.
Intervention: Denosumab (Drug)
Denosumab 6 mg every 3 months
Participants received denosumab 6 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Intervention: Denosumab (Drug)
Denosumab 30 mg every 3 months
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
Intervention: Denosumab (Drug)
Denosumab 14 mg every 3 months
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Intervention: Denosumab (Drug)
Denosumab 14 mg every 6 months
Participants received denosumab 14 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Intervention: Denosumab (Drug)
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Intervention: Alendronate (Drug)
Denosumab 210 mg every 6 months
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
Intervention: Denosumab (Drug)
Denosumab 100 mg every 6 months
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Intervention: Denosumab (Drug)
Outcomes
Primary Outcomes
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms
Time Frame: Baseline and Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Secondary Outcomes
- Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48(Baseline and 48 months)
- Serum CTX Percent Change From Baseline at Month 12(Baseline and Month 12)
- Urine NTX/Creatinine Percent Change From Baseline at Month 12(Baseline and Month 12)
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42(Baseline and 42 months)
- Serum CTX Percent Change From Baseline at Month 36(Baseline and 36 months)
- Serum CTX Percent Change From Baseline at Month 42(Baseline and 42 months)
- Serum CTX Percent Change From Baseline at Month 48(Baseline and 48 months)
- Urine NTX/Creatinine Percent Change From Baseline at Month 24(Baseline and 24 months)
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm(Baseline and Month 12)
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24(Baseline and 24 months)
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36(Baseline and 36 months)
- Total Hip Bone Mineral Density Percent Change From Baseline at Month 12(Baseline and 12 months)
- Total Hip Bone Mineral Density Percent Change From Baseline at Month 24(Baseline and 24 months)
- Total Hip Bone Mineral Density Percent Change From Baseline at Month 36(Baseline and 36 months)
- Total Hip Bone Mineral Density Percent Change From Baseline at Month 42(Baseline and 42 months)
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48(Baseline and 48 months)
- Serum CTX Percent Change From Baseline at Month 24(Baseline and 24 months)
- Urine NTX/Creatinine Percent Change From Baseline at Month 36(Baseline and 36 months)
- Urine NTX/Creatinine Percent Change From Baseline at Month 42(Baseline and 42 months)
- Urine NTX/Creatinine Percent Change From Baseline at Month 48(Baseline and 48 months)
- Total Hip Bone Mineral Density Percent Change From Baseline at Month 48(Baseline and 48 months)
- Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12(Baseline and 12 months)
- Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24(Baseline and 24 months)
- Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36(Baseline and 36 months)
- Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42(Baseline and 42 months)
- Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48(Baseline and 48 months)
- Total Body Bone Mineral Density Percent Change From Baseline at Month 12(Baseline and 12 months)
- Total Body Bone Mineral Density Percent Change From Baseline at Month 24(Baseline and 24 months)
- Total Body Bone Mineral Density Percent Change From Baseline at Month 36(Baseline and 36 months)
- Total Body Bone Mineral Density Percent Change From Baseline at Month 42(Baseline and 42 months)
- Total Body Bone Mineral Density Percent Change From Baseline at Month 48(Baseline and 48 months)
- Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12(Baseline and 12 months)
- Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24(Baseline and 24 months)
- Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36(Baseline and 36 months)
- Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42(Baseline and 42 months)