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

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 |
- Body mineral density of the 33% radius region and of the UD radius region [ Time Frame: after 90 days of treatment ]
- Body mineral density of the 33% radius region and of the UD radius region [ Time Frame: after 180 days of treatment ]
- Size of callus obtained through Rx of the fracture site. [ Time Frame: from the beginning up to the end of the study ]
- Safety: Adverse events occurrence. [ Time Frame: from the inform consent signature up to the end of the study ]

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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.

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
Brazil | |
Sanofi-Aventis Administrative Office | |
Sao Paulo, Brazil |
Study Director: | Jaderson Lima | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov 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 |
Colles' Fracture Fractures, Bone Wounds and Injuries Fracture Dislocation Joint Dislocations Joint Diseases Musculoskeletal Diseases Radius Fractures Vitamin D Cholecalciferol Risedronic Acid |
Calcium Vitamins Micronutrients Nutrients 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 |