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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Colles' Fracture

Treatments: Drug: Risedronate sodium; Drug: Calcium & Vitamine D3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00460733

RISED_L_01930

Details and patient eligibility

About

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

Enrollment: 141 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Risedronate sodium

2

Active Comparator group

Treatment:

Drug: Calcium & Vitamine D3