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

Tracking Information

First Received Date ^ICMJE

April 13, 2007

Last Updated Date

September 24, 2009

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Body mineral density of the 33% radius region and of the UD radius region [ Time Frame: after 90 days of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Body mineral density of the 33% radius region and of the UD radius region, after 90 days of treatment.

Change History

Complete list of historical versions of study NCT00460733 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Body mineral density of the 33% radius region and of the UD radius region [ Time Frame: after 180 days of treatment ] [ Designated as 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 ] [ Designated as safety issue: No ]
Safety: Adverse events occurrence. [ Time Frame: from the inform consent signature up to the end of the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Body mineral density of the 33% radius region and of the UD radius region, after 180 days of treatment.
Size of callus obtained through Rx of the fracture site.
Safety: Adverse events occurrence.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Colles' Fracture

Intervention ^ICMJE

Drug: Risedronate sodium
Drug: Calcium & Vitamine D3

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

140

Estimated Completion Date

November 2010

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Public Registry GMA

publicregistrygma@sanofi-aventis.com

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00460733

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

RISED_L_01930

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Procter and Gamble

Investigators ^ICMJE

Study Director:

Jaderson Lima

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP