Satisfaction and Compliance of Risedronate in PMO

Sanofi

Status and phase

Completed

Phase 4

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: Risedronate Sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00549965

HMR4003B_4035

Details and patient eligibility

About

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.

Enrollment

202 patients

Sex

Female

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

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.