Strategies Targeting Osteoporosis to Prevent Recurrent Fractures

Sponsor

University of Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT00152321

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

242

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Fractures	Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines). Behavioral: Multifaceted intervention Other: Usual Care	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

242 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Multifaceted intervention	Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines). Behavioral: Multifaceted intervention Educational materials, counseling, opinion leader based guidelines, reminders
Active Comparator: B Usual Care	Other: Usual Care

Arm

Intervention/Treatment

Experimental: A

Multifaceted intervention

Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines).

Behavioral: Multifaceted intervention

Educational materials, counseling, opinion leader based guidelines, reminders

Active Comparator: B

Usual Care

Other: Usual Care

Outcome Measures

Primary Outcome Measures

The proportion of patients starting bisphosphonate treatment within 6 months of fracture [6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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: