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

Colles' Fracture Clinical Trial

— SOLID  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460733
• Other study ID #: RISED_L_01930
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2007
• Last updated: October 3, 2011
• Start date: March 2007
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Procter and Gamble

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mineral density of the 33% radius region and of the UD radius region		after 90 days of treatment	No
Secondary	Body mineral density of the 33% radius region and of the UD radius region		after 180 days of treatment	No
Secondary	Size of callus obtained through Rx of the fracture site.		from the beginning up to the end of the study	No
Secondary	Safety: Adverse events occurrence.		from the inform consent signature up to the end of the study	Yes