Closing The Post Fracture Care Gap In Manitoba

NCT00594789 | Active Not Recruiting

• 1 other identifier: H2007:165
• Study Type: interventional
• Target: 4,264
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate a post-fracture intervention for improving osteoporosis care in older men and women who have suffered a fracture that may indicate the presence of osteoporosis. Although osteoporosis can be identified with a bone mineral density (BMD) test, most individuals with osteoporosis are not diagnosed until they fracture. Post-fracture care often "falls between the cracks" when there is a breakdown in communication between hospital and community, or between specialists and primary care physicians. Often physicians and patients fail to make the connection between an acute fracture and osteoporosis, or the value of secondary prevention strategies. If untreated, there is an extremely high rate of additional fractures after a first osteoporotic fracture. It follows that improving BMD testing and/or treatment in appropriately identified individuals is a necessary step in optimizing post-fracture patient care. Over the next three years we will be testing and optimizing a notification procedure to physicians and/or patients relying upon fracture events reported to the provincial health service (Manitoba Health).

Conditions

Osteoporosis

Keywords

Osteoporosis; Fractures; Bone densitometry; Dual-energy x-ray absorptiometry

Outcome Measures

Primary Outcomes (1)

• Rates of BMD testing and/or osteoporosis pharmacotherapy in the year post-fracture using the population-based provincial administrative health data repository.

  3 years (Phase 1 analysis at 1 year)

Secondary Outcomes (3)

• For individuals referred for BMD testing, an evaluation of treatment appropriateness will be performed based upon BMD results and 10-year fracture risk methods.

  3 years (Phase 1 analysis at 1 year)

• Repeat fracture rates will be also studied as a secondary endpoint.

  3 years (Phase 1 analysis at 1 year)

• An evaluation of post-fracture BMD testing and treatment rates in the years prior to the Phase 1 will also be performed to document practice patterns before the intervention.

  1 year

Study Arms (3)

1 (physician-only)

EXPERIMENTAL

Physician(s) connected with a fracture that meets study inclusion criteria.

Other: Information letters

2 (physician/patient)

EXPERIMENTAL

Physician(s) and patient connected with a fracture that meets study inclusion criteria.

Other: Information letters

Control

NO INTERVENTION

Usual care.

Interventions

Information letters OTHER

Information letters under Manitoba Health letterhead will be sent out to physician(s) and/or patient connected with a fracture that meets specific criteria. To address concerns over discontinuous care of patient seen at the time of fracture and for subsequent follow-up, the physician notification will specifically target the individual involved in the initial report to Manitoba Health as well as the primary care physician (using an algorithm developed by the Manitoba Centre for Health Policy). The notification will provide a general recommendation for osteoporosis assessment in addition to a copy of the BMD testing requisition since BMD testing is usually justified in this setting. The notification will not dictate what testing or treatment needs to be performed.

1 (physician-only); 2 (physician/patient)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men age 50 and older with one of the following fracture definitions:
• Hip fracture (physician ICD-9-CM 820-821 plus a procedure code for site-specific fracture reduction or fixation, open or closed)
• Spine fracture (physician ICD-9-CM code 805), or
• Humerus fracture (physician ICD-9-CM code 812), or
• Colles' fracture (physician ICD-9-CM code 813 plus a physician claim for site-specific fracture reduction or fixation, open or closed, or cast application).

You may not qualify if:

• Age less than 50.
• Non-Manitoba residents, cancelled Manitoba Health coverage, death or discharge to a personal care home.
• A fracture event in the previous 12 months meeting the study case definition (i.e., only a single notification per year is planned).
• Hip or wrist fractures without a procedure tariff.
• Current treatment with an osteoporosis medication.
• BMD testing within the preceding 3 years.

Sponsors & Collaborators

• The Manitoba Patient Access Network Steering Committee: collaborator
• The Manitoba Bone Density Program Committee: collaborator
• University of Manitoba: lead

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (5)

• Leslie WD, Metge C. Establishing a regional bone density program: lessons from the Manitoba experience. J Clin Densitom. 2003 Fall;6(3):275-82. doi: 10.1385/jcd:6:3:275.

  PMID: 14514998 BACKGROUND

• Caetano PA, Labine L, Klassen P, Dreilich D, Leslie WD. Closing the postfracture care gap using administrative health databases: design and implementation of a randomized controlled trial. J Clin Densitom. 2011 Oct-Dec;14(4):422-7. doi: 10.1016/j.jocd.2011.04.008. Epub 2011 Jul 1.

  PMID: 21723766 BACKGROUND

• Leslie WD, LaBine L, Klassen P, Dreilich D, Caetano PA. Closing the gap in postfracture care at the population level: a randomized controlled trial. CMAJ. 2012 Feb 21;184(3):290-6. doi: 10.1503/cmaj.111158. Epub 2011 Dec 19.

  PMID: 22184366 RESULT

• Majumdar SR, Lier DA, Leslie WD. Cost-effectiveness of two inexpensive postfracture osteoporosis interventions: results of a randomized trial. J Clin Endocrinol Metab. 2013 May;98(5):1991-2000. doi: 10.1210/jc.2013-1034. Epub 2013 Apr 17.

  PMID: 23596140 RESULT

• Cui Y, Lix LM, Yang S, Morin SN, Leslie WD. A population-based study of postfracture care in Manitoba, Canada 2000/2001-2014/2015. Osteoporos Int. 2019 Oct;30(10):2119-2127. doi: 10.1007/s00198-019-05074-8. Epub 2019 Jul 2.

  PMID: 31267162 DERIVED

Related Links

• Manitoba BMD Program

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Officials

• William D Leslie, MD MSc

  Faculty of Medicine, University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Radiology

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 16, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2011
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)