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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00460733
Recruitment Status : Completed
First Posted : April 16, 2007
Last Update Posted : October 4, 2011
Procter and Gamble
Information provided by (Responsible Party):

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

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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

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

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00460733

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Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Procter and Gamble
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Study Director: Jaderson Lima Sanofi
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Responsible Party: Sanofi Identifier: NCT00460733    
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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Colles' Fracture
Fractures, Bone
Wounds and Injuries
Fracture Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Radius Fractures
Vitamin D
Risedronic Acid
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action