Satisfaction and Compliance of Risedronate in PMO

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure compliance (50 % drug taken), and persistence.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Risedronate Sodium; Risedronic Acid

Criteria

Inclusion Criteria:

• Five (5) 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 (> than or = to 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, Risedronate.

• 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 if the subject has been in remission for at least 6 months prior to enrollment.

• Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.

• History of alcohol and/or drug abuse.

• Subjects will be excluded for active gastrointestinal disease that may interfere with absorption or with ability to swallow an oral medication.

• Subjects will also be excluded for serious concurrent illness that would interfere with their ability to participate in the trial.

• Excluded medications: bisphosphonates, calcitonin or fluoride or hormone replacement therapy within the last 6 months.

• Known hypersensitivity to bisphosphonates and/or excipients.

• Abnormal laboratory parameters, which are clinically relevant according to the Investigator (including renal insufficiency; creatinine clearance < 30 mL/min)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.