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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00280943
First Posted: January 24, 2006
Last Update Posted: October 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Duke University
  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
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00280943     History of Changes
Other Study ID Numbers: 4686-05-7R2ER
First Submitted: January 20, 2006
First Posted: January 24, 2006
Last Update Posted: October 17, 2007
Last Verified: October 2007

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
Metabolic Diseases
Femoral Fractures
Hip Injuries
Leg Injuries