A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Phase 2
Completed
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Registration Number
- NCT00293813
- Lead Sponsor
- Amgen
- Brief Summary
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 247
Inclusion Criteria
- Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health.
- Must have low bone mineral density and meet specific eligibility criteria.
Key
Exclusion Criteria
-Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Placebo Placebo for denosumab and placebo for alendronate 1 Denosumab denosumab and placebo for alendronate 2 Alendronate Placebo for denosumab and alendronate
- Primary Outcome Measures
Name Time Method Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 12 months Cortical Thickness measured by XtremeCT.
- Secondary Outcome Measures
Name Time Method Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12 12 months Cortical Thickness measured by XtremeCT.