Osteoporosis Clinical Trial
Official title:
Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)
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)
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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