Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women
Study Details
Study Description
Brief Summary
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis.
To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption.
To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- Percent change from baseline in lumbar spine bone mineral density (BMD) at []
- Month 12 measured by dual-energy X-ray absorptiometry (DXA). []
Secondary Outcome Measures
- Efficacy:Percent change from baseline in Lumbar spine BMD at times other than Month 12, Proximal femur BMD and Bone turnover markers. []
- Safety: AEs, clinical laboratory values, bone biopsies. []
- Intact serum parathyroid hormone (PTH 1-84)before treatment and after 3, 12 and 24 months of treatment in approximately 25% of randomly selected trial participants. []
- Physical examination before treatment and after 12 and 24 months of treatment. []
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects meeting all of the following criteria were considered for enrollment into the study :
·Ambulatory, healthy postmenopausal women with :
-
Natural menopause and more than 5 years after their last menstrual period.
-
Or surgical menopause and more than 5 years after surgery (blood hormone tests required for subjects less than 65 years of age who had uterus removed without removal of ovaries at time of surgery).
Osteoporosis (lumbar spine T-score more than 2.5 SD below the mean value in normal young women or more than 2.0 SD below the mean value in normal young women and at least 1 fracture of a vertebra (thoracic-lumbar T4-L4)).
Exclusion Criteria:
Subjects with any of the following criteria were not considered for enrollment into the study :
·Women who have received hormone replacement therapy (with estrogen by mouth and/or progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin, calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3 months before first dose of study medication.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis | Bridgewater | New Jersey | United States | 08807 |
| 2 | Sanofi-Aventis | San Isidro | Argentina | ||
| 3 | Sanofi-Aventis | Macquarie Park | Australia | ||
| 4 | Sanofi-Aventis | Laval | Canada | ||
| 5 | Sanofi-Aventis | Prague | Czech Republic | ||
| 6 | Sanofi-Aventis | Paris | France | ||
| 7 | Sanofi-Aventis | Beirut | Lebanon | ||
| 8 | Sanofi-Aventis | Warszawa | Poland | ||
| 9 | Sanofi-Aventis | Midrand | South Africa | ||
| 10 | Sanofi-Aventis | Istanbul | Turkey | ||
| 11 | Sanofi-Aventis | Guildford Surrey | United Kingdom |
Sponsors and Collaborators
- Sanofi
- Procter and Gamble
Investigators
- Study Director: ICD CSD, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EFC6063
- HMR4003M/3001