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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


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
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