Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities
This study has been completed.
Sponsor:
Duke University
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00280943
First received: January 20, 2006
Last updated: October 16, 2007
Last verified: October 2007
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 20, 2006 | ||||||||
| Last Updated Date | October 16, 2007 | ||||||||
| Start Date ICMJE | January 2005 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of new prescriptions for FDA-Approved osteoporosis medications. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00280943 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Secondary Outcome Measures: Changes in number of bone mineral density test ordered, change in the number of hip protectors issued, change in the number of prescriptions for calcium and vitamin D, changes in the rate of new osteoporotic fractures. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities | ||||||||
| Official Title ICMJE | Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities Written for FDA Approved Medications for Osteoporosis Treatment. | ||||||||
| Brief Summary | Osteoporotic fractures of the hip are a major cause of admission to long-term care facilities. Such fractures put patients at high risk for further fractures, pain and disability. Current data show that many patients in long-term care facilities do not receive FDA medications for their osteoporosis. This trial will test whether a multi-model intervention (which provides feedback about provider use of osteoporosis medications, information about osteoporosis, and currently approved osteoporosis medications)directed at physicians, other health care providers, and nurses will improve the number of prescriptions written for FDA approved medications for osteoporosis treatment. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Long-term care facilities in the intervention arm will receive education and feedback audit on performance | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Colon-Emeric CS, Lyles KW, House P, Levine DA, Schenck AP, Allison J, Gorospe J, Fermazin M, Oliver K, Curtis JR, Weissman N, Xie A, Saag KG. Randomized trial to improve fracture prevention in nursing home residents. Am J Med. 2007 Oct;120(10):886-92. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 64 | ||||||||
| Completion Date | March 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis |
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00280943 | ||||||||
| Other Study ID Numbers ICMJE | 4686-05-7R2ER | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Duke University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||||||
| Verification Date | October 2007 | ||||||||
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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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