Colles' Fracture
Conditions
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.
Interventions
Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3
DRUGCalcium & Vitamine D3
1000 mg of calcium and 400 UI of Vitamine D3
Sponsors
Procter and Gamble
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mineral density of the 33% radius region and of the UD radius region | after 90 days of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed