At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 181 enrolled
Drug / intervention
risedronate +3 moredrug
Likely dose
risedronate 35mgfrom 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.
Study to Assess the Efficacy, Safety and Pharmacokinetics of Risedronate Upon Oral Administration of a 35 mg Delayed-Release, a 50 mg Delayed-Release or a 35 mg Immediate-Release Administered Weekly for 13 Weeks to Postmenopausal Women
In Brief
A Phase 2 clinical trial evaluating risedronate for Postmenopausal Women. Completed, enrolled 181 participants across 6 sites.
Detailed Summary
To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Women
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
Primary CompletionJan 2007
First PostedDec 2007
TodayJul 2026
First PostedDec 20, 2007
Enrollment StartJul 1, 2006
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.5 years ago
Interventions
risedronatedrug
35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks
risedronatedrug
35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
risedronatedrug
50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
risedronatedrug
50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks