POWER Point of Care Effect on Satisfaction of Treatment
Phase 4
Completed
- Conditions
- Osteoporosis, Postmenopausal
- Registration Number
- NCT00549068
- Lead Sponsor
- Sanofi
- Brief Summary
To compare the subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel 35mg Once-a-Week for 24 weeks, and receiving feedback information, after 12 weeks of treatment, based on bone resorption marker results using the NTx Point-Of-Care (POC) device, to similar women treated as per regular clinical practice
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2433
Inclusion Criteria
- Women diagnosed with postmenopausal osteoporosis using community practice standards
- Women previously non-treated for osteoporosis, OR treated for osteoporosis with biphosphonates (alendronate, etidronate), hormone replacement therapy estrogen, estrogen-related drugs, progesterone, subcutaneous estrogen implant), raloxifene, fluoride, or calcitonin within the past 2 years but discontinued prior to enrolment into the study either due to:lack of effect or intolerance
Exclusion Criteria
- Subjects treated with Actonelr 5 mg daily,
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- Known/Suspected hypersensitivity to any component of Actonelr 35 mg Once-a-Week
- Known/Suspected hypocalcaemia
- Known/Suspected severe renal impairment (creatinine clearance < 30ml/min)
- Known/Suspected hyperparathyroidism
- Known/Suspected hyperthyroidism
- Known/Suspected active urinary tract infection
- Known high urine levels of calcium (3 4mg/ml)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Compare subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel® 35 mg Once-a-Week for 24 weeks, and receiving feedback information after 12 weeks of treatment to similar women monitored as per regular clinical practice
- Secondary Outcome Measures
Name Time Method Compare subject satisfaction with Actonel® 35 mg Once-a-Week in subject subgroups: previously treated with biphosphonates, HRT, raloxifene, fluoride, or calcitonin within past 2 years vs. those previously non treated