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

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:

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

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

Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Procter and Gamble
Investigators
Study Director: Jaderson Lima Sanofi
  More Information

No publications provided

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:
Colles' Fracture
Fractures, Bone
Radius Fractures
Wounds and Injuries
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Risedronic acid
Etidronic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013