At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 643 enrolled
Drug / intervention
Denosumab +3 morebiological
Likely dose
Denosumab 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Denosumab, Zoledronic Acid, and 2 other interventions for Post Menopausal Osteoporosis. Completed, enrolled 643 participants across 45 sites in 7 countries.
Detailed Summary
This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Menopausal Osteoporosis
CountriesAustralia, Belgium, Canada, Denmark, Poland, Spain, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedNov 2012
Primary CompletionJan 2015
TodayJul 2026
First PostedNov 26, 2012
Enrollment StartNov 7, 2012
Primary CompletionJan 7, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.6 years ago
Interventions
Denosumabbiological
Denosumab 60 mg administered by subcutaneous injection once every 6 months.
Zoledronic Aciddrug
Zoledronic acid 5 mg administered by intravenous infusion once a year
Placebo to Denosumabdrug
Administered by subcutaneous injection once every 6 months
Placebo to Zoledronic Aciddrug
Administered by intravenous infusion once a year