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

This study has been completed.
Procter and Gamble
Information provided by (Responsible Party):
Sanofi Identifier:
First received: April 13, 2007
Last updated: October 3, 2011
Last verified: October 2011
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
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:

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 ]

Secondary Outcome Measures:
  • 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 ]

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


Ages Eligible for Study:   Child, Adult, Senior
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.

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Please refer to this study by its identifier: NCT00460733

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

Responsible Party: Sanofi Identifier: NCT00460733     History of Changes
Other Study ID Numbers: RISED_L_01930
Study First Received: April 13, 2007
Last Updated: October 3, 2011

Additional relevant MeSH terms:
Fractures, Bone
Colles' Fracture
Wounds and Injuries
Radius Fractures
Vitamin D
Calcium, Dietary
Risedronate Sodium
Etidronic Acid
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017