At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 833 enrolled
Drug / intervention
Ibandronate +1 moredrug
Likely dose
Ibandronate 150mgfrom 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 Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
In Brief
A Phase 3 clinical trial evaluating Ibandronate and Denosumab for Postmenopausal Osteoporosis. Completed, enrolled 833 participants.
Detailed Summary
This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionNov 2011
Study CompletionJan 2012
TodayJul 2026
First PostedJul 10, 2009
Enrollment StartJul 1, 2009
Primary CompletionNov 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.0 years ago
Interventions
Ibandronatedrug
Ibandronate 150mg PO QM (tablet)
Denosumabdrug
denosumab 60mg SC Q6M (pre-filled syringe)