search
Back to results

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

Primary Purpose

Colles' Fracture

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Risedronate sodium
Calcium & Vitamine D3
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colles' Fracture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body mineral density of the 33% radius region and of the UD radius region
Size of callus obtained through Rx of the fracture site.
Safety: Adverse events occurrence.

Full Information

First Posted
April 13, 2007
Last Updated
October 3, 2011
Sponsor
Sanofi
Collaborators
Procter and Gamble
search

1. Study Identification

Unique Protocol Identification Number
NCT00460733
Brief Title
SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
Acronym
SOLID
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Procter and Gamble

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles' Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Risedronate sodium
Intervention Description
Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3
Intervention Type
Drug
Intervention Name(s)
Calcium & Vitamine D3
Intervention Description
1000 mg of calcium and 400 UI of Vitamine D3
Primary Outcome Measure Information:
Title
Body mineral density of the 33% radius region and of the UD radius region
Time Frame
after 90 days of treatment
Secondary Outcome Measure Information:
Title
Body mineral density of the 33% radius region and of the UD radius region
Time Frame
after 180 days of treatment
Title
Size of callus obtained through Rx of the fracture site.
Time Frame
from the beginning up to the end of the study
Title
Safety: Adverse events occurrence.
Time Frame
from the inform consent signature up to the end of the study

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaderson Lima
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs