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

This study has been completed.
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00280943
First received: January 20, 2006
Last updated: October 16, 2007
Last verified: October 2007
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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.

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of new prescriptions for FDA-Approved osteoporosis medications.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 64
Study Start Date: January 2005
Study Completion Date: March 2007
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280943

Locations
United States, North Carolina
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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00280943     History of Changes
Other Study ID Numbers: 4686-05-7R2ER
Study First Received: January 20, 2006
Last Updated: October 16, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
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:
Fractures, Bone
Osteoporosis
Hip Fractures
Osteoporotic Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 18, 2014