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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 24, 2007 | ||||
| Last Updated Date | April 22, 2008 | ||||
| Start Date ICMJE | February 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00549068 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | POWER Point of Care Effect on Satisfaction of Treatment | ||||
| Official Title ICMJE | 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 | ||||
| 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 |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Osteoporosis, Postmenopausal | ||||
| Intervention ICMJE | Drug: Risedronate Sodium (Actonel) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2433 | ||||
| Completion Date | November 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00549068 | ||||
| Responsible Party | Study Director, sanofi-aventis | ||||
| Study ID Numbers ICMJE | HMR4003B_4031 | ||||
| Study Sponsor ICMJE | Sanofi-Aventis | ||||
| Collaborators ICMJE | Procter and Gamble | ||||
| Investigators ICMJE |
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| Information Provided By | Sanofi-Aventis | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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