SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Procter and Gamble
• Treatments: Calcium; Calcium, Dietary; Cholecalciferol; Ergocalciferols; Etidronic Acid; Risedronate Sodium; Risedronic Acid; Vitamin D; Vitamins

Criteria

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.