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

Sanofi141 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

141

Conditions

Colles' Fracture

Interventions

Risedronate sodiumDRUG

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

Calcium & Vitamine D3DRUG

1000 mg of calcium and 400 UI of Vitamine D3

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Outcomes

Primary Outcomes

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

Time frame: after 90 days of treatment

Secondary Outcomes

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

Data from ClinicalTrials.gov

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