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Strategies Targeting Osteoporosis to Prevent Recurrent Fractures

Primary Purpose

Osteoporosis, Fractures

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Patients (education, counseling) and Physicians (reminders,1-page guidelines).
Multifaceted intervention
Usual Care
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, wrist fractures, quality improvement, knowledge translation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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: Age 50 years or greater, Any distal forearm fracture Exclusion Criteria: 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

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Multifaceted intervention

Usual Care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2005
Last Updated
July 25, 2015
Sponsor
University of Alberta
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00152321
Brief Title
Strategies Targeting Osteoporosis to Prevent Recurrent Fractures
Official Title
Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Fractures
Keywords
osteoporosis, wrist fractures, quality improvement, knowledge translation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Multifaceted intervention
Arm Title
B
Arm Type
Active Comparator
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Patients (education, counseling) and Physicians (reminders,1-page guidelines).
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted intervention
Intervention Description
Educational materials, counseling, opinion leader based guidelines, reminders
Intervention Type
Other
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
The proportion of patients starting bisphosphonate treatment within 6 months of fracture
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Appropriate care (BMD test performed and treatment if low bone mass)
Time Frame
6 months
Title
Bone mineral density testing
Time Frame
6 months
Title
Self reported diagnosis of osteoporosis and other knowledge
Time Frame
6 months
Title
Satisfaction with care
Time Frame
6 months
Title
Health related quality of life
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Age 50 years or greater, Any distal forearm fracture Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumit R Majumdar, MD, MPH
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18299546
Citation
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 trial. CMAJ. 2008 Feb 26;178(5):569-75. doi: 10.1503/cmaj.070981.
Results Reference
result
PubMed Identifier
20878389
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):1799-808. doi: 10.1007/s00198-010-1412-1. Epub 2010 Sep 29.
Results Reference
result
PubMed Identifier
20358359
Citation
Majumdar SR, Johnson JA, Bellerose D, McAlister FA, Russell AS, Hanley DA, Garg S, Lier DA, Maksymowych WP, Morrish DW, Rowe BH. Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study. Osteoporos Int. 2011 Jan;22(1):223-30. doi: 10.1007/s00198-010-1212-7. Epub 2010 Apr 1.
Results Reference
derived

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Strategies Targeting Osteoporosis to Prevent Recurrent Fractures

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