Satisfaction and Compliance of Risedronate in PMO

NCT ID: NCT00549965

Last Updated: 2007-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31

Brief 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.

Conditions

Osteoporosis, Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Risedronate Sodium

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Choe Seong Choon

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Daegu, , South Korea

Countries

South Korea

Other Identifiers

HMR4003B_4035

Identifier Type: -

Identifier Source: org_study_id