Strategies Targeting Osteoporosis to Prevent Recurrent Fractures

U

University of Alberta

Status

Completed

Conditions

Osteoporosis
Fractures

Treatments

Other: Usual Care
Behavioral: Multifaceted intervention
Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines).

Study type

Interventional

Funder types

Other

Identifiers

NCT00152321
University of Alberta
CIHR-MOP #62906

Details and patient eligibility

About

An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines)

Full description

Background: Osteoporosis leads to decreased bone mass, skeletal fragility, and fractures. Fractures cause disability, deformity, and even death. Osteoporosis affects 1.4 million Canadians, 25% of women and 12% of men >50 years. Current guidelines recommend aggressive secondary prevention in patients with osteoporosis and a fracture, because risk of re-fracture is as high as 20% within a year, and because treatment can reduce this risk by 40-50%. Because bisphosphonates are safe and efficacious in preventing both vertebral and nonvertebral fractures, they are the treatment of choice. Patients with a wrist fracture are ideally suited to a strategy of case-finding and secondary prevention since this is a sentinel event in the natural history of osteoporosis: wrist fractures are common and easily diagnosed, always present to medical attention, are usually related to low bone mass, and wrist fractures tend to occur years before the more devastating fractures of the hip or vertebrae. However, these patients are under-diagnosed and under-treated. Eight studies have reported that one year after a wrist fracture, fewer than 10-20% of patients >50years of age have been tested or treated for osteoporosis. A significant care gap between evidence-based best practice and usual care exists. Objective: To improve the quality of care for patients with osteoporosis and wrist fractures. Hypothesis: An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines). Specific Aims: To determine whether the proposed intervention can: Aim #1- Increase use of effective osteoporosis treatment in patients with a fracture of the wrist. Aim #2- Increase rates of bone mineral density testing in these patients. Aim #3- Increase osteoporosis-related knowledge in these patients. Aim #4- Increase satisfaction with medical care in these patients. Study Design: A prospective randomized controlled trial comparing the proposed intervention to usual care in Emergency Departments and Fracture Clinics. Eligible patients will be >50 years and present with any wrist fracture and not be taking bisphosphonates. Primary outcome is the proportion of patients starting bisphosphonate treatment within 6 months of fracture. The main secondary outcomes are starting any effective osteoporosis treatment (bisphosphonates, calcitonin, raloxifene, or hormone replacement therapy) and bone mineral density testing within 6 months. There will be blinded ascertainment of all outcomes. The intervention is expected to increase the primary outcome (bisphosphonate treatment) by at least 20% over usual care rates of 10%. With an alpha=0.05, beta=0.90, and a 20% loss to followup, the minimum required sample size is 220 patients.

Enrollment

242 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients 50 years of age or older with a wrist fracture who present to the Emergency Departments or Fracture Clinics at our two study sites will be eligible for study enrollment. Specifically:

  • Age 50 years or greater,
  • Any distal forearm fracture

Exclusion criteria

  • Unable to give simple informed consent,
  • Unwilling to participate in the study,
  • Unable to understand, read, or converse in English,
  • Place of residence outside Capital Health or longterm care facility,
  • Already receiving osteoporosis treatment with a bisphosphonate,
  • Previously documented allergy or intolerance to a bisphosphonate,
  • Currently enrolled in the pilot study or other osteoporosis study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

242 participants in 2 patient groups

A
Experimental group
Description:
Multifaceted intervention
Treatment:
Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines).
Behavioral: Multifaceted intervention
B
Active Comparator group
Description:
Usual Care
Treatment:
Other: Usual Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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