Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture

This study has been completed.
Sponsor:
Collaborator:
Alberta Heritage Foundation for Medical Research
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00175214
First received: September 10, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

The primary objective of this proposed research is to improve the quality of care for patients who present to the Emergency Department with osteoporosis and a fracture of the wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the primary study outcome, and it is defined as starting any one of hormone therapy, a bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist.

The study hypothesis is that a quality improvement intervention (with multiple components that include a notification system for primary care physicians, patient-specific reminders, locally generated treatment guidelines endorsed by opinion leaders, and patient education and counseling) will lead to increased use of proven efficacious osteoporosis treatments in patients eligible for secondary prevention. This hypothesis will be tested by comparing the intervention with usual care controls, in a prospective nonrandomized controlled trial.


Condition Intervention
Osteoporosis
Wrist Fractures
Behavioral: Multifaceted intervention (patient education, physician guidelines, reminders)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.

Secondary Outcome Measures:
  • 1. BMD testing
  • 2. Osteoporosis diagnosis
  • 3. Osteoporosis related knowledge
  • 4. Satisfaction
  • 5. Generic, Disease Specific, and Function-related QOL
  • 6. Falls, falls-related injuries, and fall interventions
  • 7. Persistence of effects and generalizability of effects
  • 8. 1, 2, 3 year outcomes

Estimated Enrollment: 160
Study Start Date: January 2001
Estimated Study Completion Date: January 2005
Detailed Description:

BACKGROUND: Osteoporosis is a progressive condition that causes a loss of bone mass, skeletal fragility, and fractures. Fractures result in pain, disability, deformity, and death. Osteoporosis is a major population health problem affecting 1.4 million Canadians, 25% of women and 12% of men over the age of 50 years. Current guidelines recommend aggressive secondary prevention in patients with osteoporosis who have suffered a fracture, because these patients have as high as a 20% risk of fracture in the following year, and because there are now proven efficacious treatments that can reduce this risk by 40-60%. Nevertheless, recent studies have shown that these patients are under-recognized and under-treated, demonstrating a care gap between evidence-based best practice and usual care. All patients with osteoporotic fractures (i.e., of the hip, vertebrae, or wrist) benefit from treatment. However, patients who present with a wrist fracture may be best suited to an intervention to improve secondary prevention practices, because wrist fractures are “sentinel events” in the natural history of osteoporosis: they are common, easily diagnosed, always present to medical attention, and occur years before the more devastating and costly fractures of the hip and vertebrae.

OBJECTIVES: The primary objective of this study is to improve the quality of care for patients who present to the ED with osteoporosis and a fracture of the wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the primary study outcome, and it is defined as starting any one of hormone replacement therapy, a bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist.

HYPOTHESIS: A quality improvement intervention directed at patients and their primary care physicians will increase the use of proven efficacious osteoporosis treatment. The intervention itself has multiple components that include: a notification system and patient-specific reminders for primary care physicians, locally developed treatment guidelines endorsed by opinion leaders, and patient education and counseling. The study hypothesis will be tested by comparing the intervention to usual care controls, in a prospective nonrandomized controlled trial.

SPECIFIC AIMS: To determine whether the proposed intervention can-

  • 1. Increase the use of proven efficacious osteoporosis treatment in patients with a fracture of the wrist,
  • 2. Increase appropriate use of bone mineral density testing,
  • 3. Increase patients’ knowledge of osteoporosis and satisfaction.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 50 years
  • any closed distal forearm fracture
  • discharged home

Exclusion Criteria:

  • unwilling or unable to provide consent
  • admitted to hospital
  • long term care resident
  • residence outside Edmonton, Alberta
  • unable to read and converse in English
  • currently taking prescription osteoporosis treatment
  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: NCT00175214

Locations
Canada, Alberta
University of Alberta Hospitals
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Alberta Heritage Foundation for Medical Research
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):
ClinicalTrials.gov Identifier: NCT00175214     History of Changes
Other Study ID Numbers: AHFMR#2000000389
Study First Received: September 10, 2005
Last Updated: September 10, 2005
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
osteoporosis
wrist fractures
quality improvement
knowledge translation

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

ClinicalTrials.gov processed this record on July 31, 2014