At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 285 enrolled
Drug / intervention
Placebo tablet +1 moredrug
Likely dose
Placebo tablet 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.
Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study
In Brief
A Phase 3 clinical trial evaluating Placebo tablet and Risedronate for Other Osteoporosis. Completed, enrolled 285 participants across 23 sites in 10 countries.
Detailed Summary
Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOther Osteoporosis
CountriesAustralia, Belgium, Czechia, France, Hungary, Lebanon, Netherlands, Poland, United Kingdom, United States
CollaboratorsSanofi
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2002
Primary CompletionMay 2007
First PostedFeb 2008
TodayJul 2026
First PostedFeb 21, 2008
Enrollment StartJun 1, 2002
Primary CompletionMay 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.4 years ago
Interventions
Placebo tabletdrug
one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
Risedronatedrug
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years