At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 50 enrolled
Drug / intervention
risedronate +1 moredrug
Likely dose
risedronate 35 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.
The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men
In Brief
A Phase 4 clinical trial evaluating risedronate and Placebo risedronate oral tablet for Prostate Cancer. Completed, enrolled 50 participants across 1 site.
Detailed Summary
Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsProctor and Gamble/Aventis
Timeline
Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2003
Primary CompletionMar 2008
Study CompletionFeb 2009
First PostedMar 2009
TodayJul 2026
First PostedMar 10, 2009
Enrollment StartJan 1, 2003
Primary CompletionMar 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 17.3 years ago
Interventions
risedronatedrug
35 mg/week by mouth
Placebo risedronate oral tabletdrug
One tablet by mouth every week as directed