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

Sponsor:	Sanofi-Aventis
Collaborator:	Procter and Gamble
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00460733

Purpose

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

Condition	Intervention	Phase
Colles' Fracture	Drug: Risedronate sodium Drug: Calcium & Vitamine D3	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Fractures Minerals

Drug Information available for: alpha-Tocopheryl acetate alpha-Tocopherol Risedronic acid Risedronate sodium Calcium gluconate Vitamin E Tocopherols Tocotrienol

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	140
Study Start Date:	March 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Risedronate sodium Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3
2: Active Comparator	Drug: Calcium & Vitamine D3 1000 mg of calcium and 400 UI of Vitamine D3

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460733

Contacts

Contact: Public Registry GMA

publicregistrygma@sanofi-aventis.com

Locations

Brazil
Sanofi-aventis Administrative Office	Recruiting
Sao Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Procter and Gamble

Investigators

Study Director:

Jaderson Lima

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	RISED_L_01930
Study First Received:	April 13, 2007
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00460733 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:

Etidronic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Fractures, Bone
Physiological Effects of Drugs
Wounds and Injuries
Calcium Channel Blockers
Disorders of Environmental Origin
Bone Density Conservation Agents
Cardiovascular Agents

Radius Fractures
Protective Agents
Pharmacologic Actions
Membrane Transport Modulators
Vitamin E
Therapeutic Uses
Vitamins
Colles' Fracture
Micronutrients
Risedronic acid

ClinicalTrials.gov processed this record on November 30, 2009