Strategies Targeting Osteoporosis to Prevent Recurrent Fractures
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|ClinicalTrials.gov Identifier: NCT00152321|
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : July 28, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Fractures||Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines). Behavioral: Multifaceted intervention Other: Usual Care||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||242 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2010|
Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines).
Behavioral: Multifaceted intervention
Educational materials, counseling, opinion leader based guidelines, reminders
Active Comparator: B
Other: Usual Care
- The proportion of patients starting bisphosphonate treatment within 6 months of fracture [ Time Frame: 6 months ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152321
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||Sumit R Majumdar, MD, MPH||University of Alberta|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Sumit R. Majumdar, University of Alberta|
|Other Study ID Numbers:||
University of Alberta
|First Posted:||September 9, 2005 Key Record Dates|
|Last Update Posted:||July 28, 2015|
|Last Verified:||July 2015|
Wounds and Injuries
Bone Diseases, Metabolic