POWER Point of Care Effect on Satisfaction of Treatment

Study Overview
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Brief Summary
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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

Official Title
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Impact of NTx Point of Care (POC) Device on Patient Satisfication With Actonel 35mg Once a Seek Treatment a Multicenter Prospective Open Label Randomized Controlled Community Practice-based Study

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Drug: Risedronate Sodium (Actonel)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risedronate Sodium (Actonel)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |