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

Osteoporosis Clinical Trial

Official title:

Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities Written for FDA Approved Medications for Osteoporosis Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280943
• Other study ID #: 4686-05-7R2ER
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2005
• Est. completion date: March 2007

Study information

• Verified date: October 2007
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Osteoporosis
• Osteoporotic Fractures

Intervention

Behavioral:
• Long-term care facilities in the intervention arm will receive education and feedback audit on performance

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of new prescriptions for FDA-Approved osteoporosis medications.
Secondary	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.