Official Title: “Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodium Usage in the Consolidation and in the Callus of the Colles'Fracture.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2009

Intervention(s) in this Clinical Trial

• Drug: Risedronate sodium
  • Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3
• Drug: Calcium & Vitamine D3
  • 1000 mg of calcium and 400 UI of Vitamine D3

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Body mineral density of the 33% radius region and of the UD radius region
  • Time Frame: after 90 days of treatment
    Safety Issue?: No

Secondary Measures

• Body mineral density of the 33% radius region and of the UD radius region
  • Time Frame: after 180 days of treatment
    Safety Issue?: No
• Size of callus obtained through Rx of the fracture site.
  • Time Frame: from the beginning up to the end of the study
    Safety Issue?: No
• Safety: Adverse events occurrence.
  • Time Frame: from the inform consent signature up to the end of the study
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Jaderson Lima Study Director Sanofi-Aventis  

Overall Contact: Public Registry GMA  publicregistrygma@sanofi-aventis.com

Information obtained from ClinicalTrials.gov on September 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00460733

Study ID Number: RISED_L_01930

ClinicalTrials.gov Identifier: NCT00460733

Health Authority: Brazil: National Health Surveillance Agency