Status:
COMPLETED
A Study of Monthly Risedronate for Osteoporosis
Lead Sponsor:
Warner Chilcott
Collaborating Sponsors:
Sanofi
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Detailed Description
The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.
Eligibility Criteria
Inclusion
- Female: 50 years of age or older
- \>5 years since last menses natural or surgical
- have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
Exclusion
- history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
- BMI (body mass index) \>32 kg/m\^2
- use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
- hypocalcemia or hypercalcemia of any cause
- markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
1294 Patients enrolled
Trial Details
Trial ID
NCT00247273
Start Date
October 1 2005
End Date
April 1 2008
Last Update
April 22 2013
Active Locations (49)
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1
Research Site
Lakewood, Colorado, United States, 80227
2
Research Site
Gainesville, Georgia, United States, 30501
3
Research Site
Bethesda, Maryland, United States, 20817
4
Research Site
Omaha, Nebraska, United States, 068131