SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
SOLID
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.
1 other identifier
interventional
141
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 13, 2007
CompletedFirst Posted
Study publicly available on registry
April 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 4, 2011
October 1, 2011
4.5 years
April 13, 2007
October 3, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Body mineral density of the 33% radius region and of the UD radius region
after 90 days of treatment
Secondary Outcomes (3)
Body mineral density of the 33% radius region and of the UD radius region
after 180 days of treatment
Size of callus obtained through Rx of the fracture site.
from the beginning up to the end of the study
Safety: Adverse events occurrence.
from the inform consent signature up to the end of the study
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Procter and Gamblecollaborator
Study Sites (1)
Sanofi-Aventis Administrative Office
São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jaderson Lima
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2007
First Posted
April 16, 2007
Study Start
March 1, 2007
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 4, 2011
Record last verified: 2011-10