POWER Point of Care Effect on Satisfaction of Treatment
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis, Postmenopausal
Intervention: Risedronate Sodium (Actonel) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Mary Tzortzis, Study Director, Affiliation: Sanofi-Aventis
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
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Additional Information
clinicalstudyresults.org
Starting date: February 2003
Ending date: November 2004
Last updated: April 22, 2008
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