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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Alendronate; Denosumab

Criteria

Key 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.