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Clinical trial

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

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Last updated:20th Nov 2012

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

Category Value
Study start date 2012-11-20

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