Addressing Vertebral Osteoporosis Incidentally Detected to Prevent Future Fractures

NCT00388908 | Completed

• 1 other identifier: CIHR-MOP-79325
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis

Keywords

vertebral fractures; osteoporosis; prevention; case-finding; quality improvement

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the proportion of patients starting prescription osteoporosis treatment within 3 months of fracture recognition

  3 months

Secondary Outcomes (1)

• Secondary outcomes include BMD testing, diagnosis of osteoporosis, knowledge, and quality of life.

  3 months

Study Arms (2)

A

EXPERIMENTAL

Multifaceted intervention

Behavioral: Reminders and opinion leader generated guidelines +/- leaflets and counselling

B

ACTIVE COMPARATOR

Usual Care

Other: Usual Care

Interventions

Reminders and opinion leader generated guidelines +/- leaflets and counselling BEHAVIORAL

A

Usual Care OTHER

B

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (4)

• Kim N, Rowe BH, Raymond G, Jen H, Colman I, Jackson SA, Siminoski KG, Chahal AM, Folk D, Majumdar SR. Underreporting of vertebral fractures on routine chest radiography. AJR Am J Roentgenol. 2004 Feb;182(2):297-300. doi: 10.2214/ajr.182.2.1820297.

  PMID: 14736649 BACKGROUND

• Majumdar SR, Kim N, Colman I, Chahal AM, Raymond G, Jen H, Siminoski KG, Hanley DA, Rowe BH. Incidental vertebral fractures discovered with chest radiography in the emergency department: prevalence, recognition, and osteoporosis management in a cohort of elderly patients. Arch Intern Med. 2005 Apr 25;165(8):905-9. doi: 10.1001/archinte.165.8.905.

  PMID: 15851642 BACKGROUND

• Majumdar SR, McAlister FA, Johnson JA, Bellerose D, Siminoski K, Hanley DA, Qazi I, Lier DA, Lambert RG, Russell AS, Rowe BH. Interventions to increase osteoporosis treatment in patients with 'incidentally' detected vertebral fractures. Am J Med. 2012 Sep;125(9):929-36. doi: 10.1016/j.amjmed.2012.02.021.

  PMID: 22938928 RESULT

• Majumdar SR, Lier DA, McAlister FA, Rowe BH, Siminoski K, Hanley DA, Russell AS, Johnson JA. Cost-effectiveness of osteoporosis interventions for 'incidental' vertebral fractures. Am J Med. 2013 Feb;126(2):169.e9-17. doi: 10.1016/j.amjmed.2012.10.009.

  PMID: 23331449 RESULT

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures

Interventions

Counseling

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sumit R. Majumdar, MD, MPH

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 17, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2012
• Last Updated: April 11, 2022

Record last verified: 2015-07

Locations

CA (1)