Satisfaction and Compliance of Risedronate in PMO
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00549965
First received: October 24, 2007
Last updated: October 26, 2007
Last verified: October 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis, Postmenopausal |
Drug: Risedronate Sodium |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Phase IV Study in Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Actonel(Rosedronate) is Administered 35mg Once a Week or 5mg |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Risedronate sodium
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Measurement of subject satisfaction of once a week 35 mg Risedronate and once daily 5 mg Risedronate. [ Time Frame: A subject-administered questionnaire at 12 and 24 weeks will assess satisfaction. ]
Secondary Outcome Measures:
- The subjects' compliance and persistence on treatment. Compliance as defined by more than 50% of the drug taken (by tablet count) during each Risedronate treatment period. [ Time Frame: Persistence at week 12 and 24 will be defined as continuing Risedronate treatment. ]
| Enrollment: | 202 |
| Study Start Date: | October 2003 |
Eligibility| Ages Eligible for Study: | 55 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00549965 History of Changes |
| Other Study ID Numbers: | HMR4003B_4035 |
| Study First Received: | October 24, 2007 |
| Last Updated: | October 26, 2007 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Risedronic acid Etidronic Acid Bone Density Conservation Agents |
Physiological Effects of Drugs Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013