Strategies Targeting Osteoporosis to Prevent Recurrent Fractures

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152321
• Other study ID #: University of Alberta
• Secondary ID: CIHR-MOP #62906
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: July 25, 2015
• Start date: September 2003
• Est. completion date: March 2010

Study information

• Verified date: July 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: March 2010
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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:

1. Age 50 years or greater,

2. Any distal forearm fracture

Exclusion Criteria:

1. Unable to give simple informed consent,

2. Unwilling to participate in the study,

3. Unable to understand, read, or converse in English,

4. Place of residence outside Capital Health or longterm care facility,

5. Already receiving osteoporosis treatment with a bisphosphonate,

6. Previously documented allergy or intolerance to a bisphosphonate,

7. Currently enrolled in the pilot study or other osteoporosis study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures
• Fractures, Bone
• Osteoporosis

Intervention

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

• Multifaceted intervention
Educational materials, counseling, opinion leader based guidelines, reminders

Other:
• Usual Care

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Majumdar SR, Johnson JA, McAlister FA, Bellerose D, Russell AS, Hanley DA, Morrish DW, Maksymowych WP, Rowe BH. Multifaceted intervention to improve diagnosis and treatment of osteoporosis in patients with recent wrist fracture: a randomized controlled tr — View Citation

Majumdar SR, Lier DA, Rowe BH, Russell AS, McAlister FA, Maksymowych WP, Hanley DA, Morrish DW, Johnson JA. Cost-effectiveness of a multifaceted intervention to improve quality of osteoporosis care after wrist fracture. Osteoporos Int. 2011 Jun;22(6):1799 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients starting bisphosphonate treatment within 6 months of fracture		6 months	No
Secondary	Appropriate care (BMD test performed and treatment if low bone mass)		6 months	No
Secondary	Bone mineral density testing		6 months	No
Secondary	Self reported diagnosis of osteoporosis and other knowledge		6 months	No
Secondary	Satisfaction with care		6 months	No
Secondary	Health related quality of life		6 months	Yes