At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 870 enrolled
Drug / intervention
Actonel® +1 moredrug
Likely dose
Actonel® 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 Monthly Actonel® Therapies in Postmenopausal Women Transitioned From Weekly or Daily Alendronate Therapy
In Brief
A Phase 3 clinical trial evaluating Actonel® and Denosumab for Osteoporosis. Completed, enrolled 870 participants.
Detailed Summary
A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily Alendronate therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartSep 2009
Primary CompletionDec 2011
Study CompletionMar 2012
TodayJul 2026
First PostedJun 12, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 21, 2011
Study CompletionMar 5, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.1 years ago
Interventions
Actonel®drug
Oral Actonel® (Risedronate) in total a 150mg per month (one 75mg tablet to be taken on each of 2 consecutive days per month).
Denosumabdrug
Denosumab 60 mg, once every 6 months, Subcutaneous