Status:
COMPLETED
SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Procter and Gamble
Conditions:
Colles' Fracture
Eligibility:
FEMALE
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00460733
Start Date
March 1 2007
End Date
September 1 2011
Last Update
October 4 2011
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
São Paulo, Brazil