Status:
COMPLETED
Risedronate Sodium in Post Menopausal Osteoporosis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Procter and Gamble
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
55-80 years
Phase:
PHASE4
Brief Summary
The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women. The secondary objectives are...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Five years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.
- Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (≥ 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Actonel.
- Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication, they may be given at the discretion of the Investigator.
- Exclusion criteria :
- Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion criteria if the subject has been in remission for at least 6 months prior to enrollment.
- Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00453492
Start Date
January 1 2004
Last Update
March 11 2008
Active Locations (1)
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1
Sanofi-Aventis
Istanbul, Turkey (Türkiye)