Status:
COMPLETED
Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Procter and Gamble
Conditions:
Osteoporosis Postmenopausal
Eligibility:
FEMALE
50+ years
Phase:
PHASE3
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 postmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
1231 Patients enrolled
Trial Details
Trial ID
NCT00358176
Start Date
July 1 2004
End Date
March 1 2007
Last Update
December 15 2009
Active Locations (11)
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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