Clinical Trial: Strategies Targeting Osteoporosis to Prevent Recurrent Fractures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)

Brief Summary: 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)

Detailed Summary:

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:
Sponsor: University of Alberta

Current Primary Outcome: The proportion of patients starting bisphosphonate treatment within 6 months of fracture [ Time Frame: 6 months ]

Original Primary Outcome: The proportion of patients starting bisphosphonate treatment within 6 months of fracture

Current Secondary Outcome:

  • Appropriate care (BMD test performed and treatment if low bone mass) [ Time Frame: 6 months ]
  • Bone mineral density testing [ Time Frame: 6 months ]
  • Self reported diagnosis of osteoporosis and other knowledge [ Time Frame: 6 months ]
  • Satisfaction with care [ Time Frame: 6 months ]
  • Health related quality of life [ Time Frame: 6 months ]


Original Secondary Outcome:

  • The main secondary outcomes are:
  • (1)starting any effective osteoporosis treatment (bisphosphonates, calcitonin, raloxifene, or hormone therapy),
  • (2)bone mineral density testing,
  • (3)self reported diagnosis of osteoporosis and other knowledge,
  • (4)satisfaction with care,
  • (5)health related quality of life


Information By: University of Alberta

Dates:
Date Received: September 7, 2005
Date Started: September 2003
Date Completion:
Last Updated: July 25, 2015
Last Verified: July 2015