SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
Phase 4
Completed
- Conditions
- Colles' Fracture
- Interventions
- Registration Number
- NCT00460733
- Lead Sponsor
- Sanofi
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 141
Inclusion Criteria
- Women with description of 2 or more years of Menopause;
- T-score <= -2.0 sd;
- Confirmed colles'fracture;
- Independent for the march (preserved ambulatorial ability);
Exclusion Criteria
- Co-morbidities;
- Regular use of corticosteroids or other anti-resorptive drug in the last year;
- Use of drugs that can affect the calcium metabolism;
- Hypersensitivity to risedronate;
- Previous wrist or forearm fracture;
- Hypocalcemia;
- Renal insufficiency;
- Rheumatic disease;
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Calcium & Vitamine D3 - 1 Risedronate sodium -
- Primary Outcome Measures
Name Time Method Body mineral density of the 33% radius region and of the UD radius region after 90 days of treatment
- Secondary Outcome Measures
Name Time Method Size of callus obtained through Rx of the fracture site. from the beginning up to the end of the study Safety: Adverse events occurrence. from the inform consent signature up to the end of the study Body mineral density of the 33% radius region and of the UD radius region after 180 days of treatment
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇧🇷Sao Paulo, Brazil