Strategies Targeting Osteoporosis to Prevent Recurrent Fractures
Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)
Sponsor: Canadian Institutes of Health Research (CIHR)
Listed as NCT00152321, this NA trial focuses on Fractures and Osteoporosis and remains completed. Sponsored by Canadian Institutes of Health Research (CIHR), it has been updated 6 times since 2003, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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...
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.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed NA
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Sep 2024 — Present [monthly]
Completed NA
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Jul 2024 — Sep 2024 [monthly]
Completed NA
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Jan 2021 — Jul 2024 [monthly]
Completed NA
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Jun 2018 — Jan 2021 [monthly]
Completed NA
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed NA
First recorded
Sep 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Canadian Institutes of Health Research (CIHR)
- University of Alberta
For direct contact, visit the study record on ClinicalTrials.gov .