Addressing Vertebral Osteoporosis Incidentally Detected to Prevent Future Fractures (AVOID Fracture)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Alberta.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00388908
First received: October 16, 2006
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

Osteoporosis is a common and progressive condition that leads to broken bones (fractures), which cause pain, disability, deformity, and even death. There are new treatments available that can decrease the risk of a fracture by 50%, and the people who benefit the most are those with osteoporosis who have already had a fracture, like a vertebral (spine) fracture. Vertebral fractures are usually "silent," and ~20% of people over the age of 60 years have had one although they don't know it. Many of these people have had chest x-rays done for other reasons, and these x-rays can incidentally detect these silent fractures. Although most people with a vertebral fracture should be tested and treated for osteoporosis, studies demonstrate that less than one-quarter of older people with a vertebral fracture are ever investigated or even treated. This reflects a gap between evidence-based best practice and everyday practice in the community. The proposed research addresses this care-gap by using a quality improvement intervention that uses chest x-rays done in the Emergency Department to remind family physicians about osteoporosis while providing them with evidence-based treatment guidelines - with or without educating and empowering patients about osteoporosis. The effectiveness of this intervention will be compared to usual care in a controlled trial. The intent of this research is to improve quality of care for patients at high risk of fracture, by increasing rates of testing and treatment of osteoporosis.


Condition Intervention
Osteoporosis
Behavioral: Reminders and opinion leader generated guidelines +/- leaflets and counselling
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Addressing Vertebral Osteoporosis Incidentally Detected to Prevent Future Fractures: The AVOID FRACTURE Study

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • The primary outcome is the proportion of patients starting prescription osteoporosis treatment within 3 months of fracture recognition [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes include BMD testing, diagnosis of osteoporosis, knowledge, and quality of life. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: November 2006
Estimated Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Multifaceted intervention
Behavioral: Reminders and opinion leader generated guidelines +/- leaflets and counselling
Active Comparator: B
Usual Care
Other: Usual Care
Other Name: Usual Care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 60 years or greater
  • chest radiograph that reports the presence of a vertebral fracture
  • discharged home.

Exclusion Criteria:

  • unable to provide simple informed consent or unwilling to participate in the study
  • unable to read, understand, and converse in English
  • admitted to hospital
  • currently enrolled in the pilot study or other osteoporosis-related studies
  • currently taking any prescription osteoporosis treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388908

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Sumit R. Majumdar, MD, MPH University of Alberta
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sumit R. Majumdar, University of Alberta
ClinicalTrials.gov Identifier: NCT00388908     History of Changes
Other Study ID Numbers: CIHR-MOP-79325
Study First Received: October 16, 2006
Last Updated: May 9, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
vertebral fractures
osteoporosis
prevention
case-finding
quality improvement

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014