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

This study has been completed.

Sponsor:

Collaborator:

Procter and Gamble

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00460733

First received: April 13, 2007

Last updated: October 3, 2011

Last verified: October 2011

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 Vitamin D

Drug Information available for: Cholecalciferol Calcium Gluconate Vitamin D Risedronate sodium

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ]


Enrollment:	141
Study Start Date:	March 2007
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil

Sponsors and Collaborators

Sanofi

Procter and Gamble

Investigators


Study Director:	Jaderson Lima	Sanofi

More Information


Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00460733 History of Changes
Other Study ID Numbers:	RISED_L_01930
Study First Received:	April 13, 2007
Last Updated:	October 3, 2011
Health Authority:	Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:


Fractures, Bone Colles' Fracture Wounds and Injuries Radius Fractures Vitamins Vitamin D Ergocalciferols Cholecalciferol Calcium, Dietary	Risedronate Sodium Etidronic Acid Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016

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