Osteoporosis, Postmenopausal
Conditions
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
Interventions
Sponsors
Procter and Gamble
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Outcome results
None listed