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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

April 13, 2007
October 3, 2011
March 2007
September 2011   (final data collection date for primary outcome measure)
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 ]
Body mineral density of the 33% radius region and of the UD radius region, after 90 days of treatment.
Complete list of historical versions of study NCT00460733 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Body mineral density of the 33% radius region and of the UD radius region, after 180 days of treatment.
  • Size of callus obtained through Rx of the fracture site.
  • Safety: Adverse events occurrence.
Not Provided
Not Provided
 
SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
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.

The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colles' Fracture
  • Drug: Risedronate sodium
    Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3
  • Drug: Calcium & Vitamine D3
    1000 mg of calcium and 400 UI of Vitamine D3
  • Experimental: 1
    Intervention: Drug: Risedronate sodium
  • Active Comparator: 2
    Intervention: Drug: Calcium & Vitamine D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
September 2011
September 2011   (final data collection date for primary outcome measure)

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.

Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00460733
RISED_L_01930
Not Provided
Sanofi
Sanofi
Procter and Gamble
Study Director: Jaderson Lima Sanofi
Sanofi
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP