POWER Point of Care Effect on Satisfaction of Treatment
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00549068
First received: October 24, 2007
Last updated: December 4, 2009
Last verified: December 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis, Postmenopausal |
Drug: Risedronate Sodium (Actonel) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Risedronate sodium
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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:
- 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
| Enrollment: | 2433 |
| Study Start Date: | February 2003 |
| Study Completion Date: | November 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00549068 History of Changes |
| Other Study ID Numbers: | HMR4003B_4031 |
| Study First Received: | October 24, 2007 |
| Last Updated: | December 4, 2009 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Risedronic acid Etidronic Acid Bone Density Conservation Agents |
Physiological Effects of Drugs Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013