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

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ClinicalTrials.gov Identifier: NCT00460733
Recruitment Status : Completed
First Posted : April 16, 2007
Last Update Posted : October 4, 2011
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Sanofi

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colles' Fracture Drug: Risedronate sodium Drug: Calcium & Vitamine D3 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : March 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Body mineral density of the 33% radius region and of the UD radius region [ Time Frame: after 90 days of treatment ]

Secondary Outcome Measures :
  1. Body mineral density of the 33% radius region and of the UD radius region [ Time Frame: after 180 days of treatment ]
  2. Size of callus obtained through Rx of the fracture site. [ Time Frame: from the beginning up to the end of the study ]
  3. Safety: Adverse events occurrence. [ Time Frame: from the inform consent signature up to the end of the study ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460733


Locations
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Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Procter and Gamble
Investigators
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Study Director: Jaderson Lima Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00460733     History of Changes
Other Study ID Numbers: RISED_L_01930
First Posted: April 16, 2007    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
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Fractures, Bone
Colles' Fracture
Wounds and Injuries
Fracture Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Radius Fractures
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
 Risedronic Acid
Etidronic Acid
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action