Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00280943
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Duration (Months): 25.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures; Osteoporosis	Behavioral: Long-term care facilities in the intervention arm will receive education and feedback audit on performance	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single
• Primary Purpose: Prevention
• Official Title: Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities Written for FDA Approved Medications for Osteoporosis Treatment.
• Study Start Date: Jan 1, 2005
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

1. Number of new prescriptions for FDA-Approved osteoporosis medications. []

Secondary Outcome Measures

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Kenneth W Lyles, M.D., Duke University
• Principal Investigator: Cathleen S. Colon-Emeric, MD, MHSc, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00280943
• Other Study ID Numbers: 4686-05-7R2ER
• First Posted: Jan 24, 2006
• Last Update Posted: Oct 17, 2007
• Last Verified: Oct 1, 2007

• Keywords provided by , ,: All NC LTC facilities having ten residents with a hip fracture or osteoporosis on the MDS will be invited to participate in the trial
• Additional relevant MeSH terms: Osteoporosis; Fractures, Bone; Hip Fractures; Osteoporotic Fractures

Study Results

No Results Posted as of Oct 17, 2007