POWER Point of Care Effect on Satisfaction of Treatment

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Procter and Gamble
• Treatments: Risedronate Sodium; Risedronic Acid

Criteria

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.