Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

This study will compare the effectiveness of Denosumab treatment Q6M with once yearly Zoledronic Acid treatment on Bone Mineral Density (BMD) at various skeletal sites.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
Enrollment: 643
Study Start Date: November 2012
Study Completion Date: March 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Denosumab 60 mg SC Q6M
- Active Comparator: Zoledronic Acid 5 mg IV once yearly