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

NCT ID: NCT00460733

Last Updated: 2011-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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Conditions

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Colles' Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Risedronate sodium

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

Calcium & Vitamine D3

Intervention Type DRUG

1000 mg of calcium and 400 UI of Vitamine D3

Interventions

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Risedronate sodium

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

Intervention Type DRUG

Calcium & Vitamine D3

1000 mg of calcium and 400 UI of Vitamine D3

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaderson Lima

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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RISED_L_01930

Identifier Type: -

Identifier Source: org_study_id