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Completed

NCT Number: NCT00460733

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

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

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Key information

Conditions

Colles' Fracture Fracture Dislocation Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Radius Fractures Wounds and Injuries

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

risedronate sodium

Drug

Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3

Calcium & Vitamine D3

Drug

1000 mg of calcium and 400 UI of Vitamine D3

Primary outcomes

  1. Body mineral density of the 33% radius region and of the UD radius region

    Time frame: after 90 days of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Procter and Gamble

Registry information

Official study 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.

Acronym: SOLID

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 16, 2007
Registry last updated
Oct 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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