Status:
COMPLETED
Risedronate in Osteopenic Postmenopausal Women
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Procter and Gamble
Conditions:
Osteoporosis
Eligibility:
FEMALE
55-75 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenop...
Eligibility Criteria
Inclusion
- Osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (BMI) \< 30 kg/m²
Exclusion
- Clinical or radiological evidence of osteoporosis
- Severe renal impairment
- Serum 5-hydroxy vitamin D level \< 15 ng/ml
- History of recent primary hyperparathyroidism or recent thyroid disorder
- History of any generalized bone disease
- Current use of glucocorticoids, estrogens, progestins, calcium supplements \> 1 g/day, vitamin D supplements \> 800 IU/day, parathyroid hormone (PTH), or any bisphosphonate for \> 1 month at any time within the past 6 months.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00345644
Start Date
March 1 2006
End Date
June 1 2009
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis
Paris, France