Clinical Trial: SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodiu
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.
Detailed Summary:
Sponsor: Sanofi
Current Primary Outcome: Body mineral density of the 33% radius region and of the UD radius region [ Time Frame: after 90 days of treatment ]
Original Primary Outcome: Body mineral density of the 33% radius region and of the UD radius region, after 90 days of treatment.
Current Secondary Outcome:
- Body mineral density of the 33% radius region and of the UD radius region [ Time Frame: after 180 days of treatment ]
- Size of callus obtained through Rx of the fracture site. [ Time Frame: from the beginning up to the end of the study ]
- Safety: Adverse events occurrence. [ Time Frame: from the inform consent signature up to the end of the study ]
Original Secondary Outcome:
- Body mineral density of the 33% radius region and of the UD radius region, after 180 days of treatment.
- Size of callus obtained through Rx of the fracture site.
- Safety: Adverse events occurrence.
Information By: Sanofi
Dates:
Date Received: April 13, 2007
Date Started: March 2007
Date Completion:
Last Updated: October 3, 2011
Last Verified: October 2011
