POWER Point of Care Effect on Satisfaction of Treatment
Status and phase
Completed
Phase 4
Conditions
Osteoporosis, Postmenopausal
Treatments
Drug: Risedronate Sodium (Actonel)
Details and patient eligibility
About
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
Enrollment
2,433 patients
Sex
Female
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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