Status:
COMPLETED
Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Procter and Gamble
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
45+ years
Phase:
PHASE3
Brief Summary
To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women To confirm the efficacy of 5 mg d...
Eligibility Criteria
Inclusion
- 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
- osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women).
- With at least one risk factor for osteoporosis
Exclusion
- Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00353080
Start Date
December 1 2002
End Date
April 1 2005
Last Update
December 15 2009
Active Locations (5)
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1
Sanofi-Aventis
Helsinki, Finland
2
Sanofi-Aventis
Gouda, Netherlands
3
Sanofi-Aventis
Oslo, Norway
4
Sanofi-Aventis
Madrid, Spain