NCT00330460

A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.

A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Denisty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,189 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects receiving alendronate sodium by more than a pre-specified non-inferiority margin.

Conditions

• Osteoporosis
• Osteopenia

Interventions

Type	Name	Description
DRUG	Alendronate	ALN; 70 mg; oral; once weekly
DRUG	Denosumab	60 mg; SC; every 6 months

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-11-01
• Completion: 2008-01-01
• First posted: 2006-05-26
• Last updated: 2011-01-24
• Results posted: 2010-07-19