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Strategies Targeting Osteoporosis to Prevent Recurrent Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00152321
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : July 28, 2015
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Alberta

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 9, 2005
Last Update Posted Date July 28, 2015
Study Start Date  ICMJE September 2003
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2008)
The proportion of patients starting bisphosphonate treatment within 6 months of fracture [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
The proportion of patients starting bisphosphonate treatment within 6 months of fracture
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • The main secondary outcomes are:
  • (1)starting any effective osteoporosis treatment (bisphosphonates, calcitonin, raloxifene, or hormone therapy),
  • (2)bone mineral density testing,
  • (3)self reported diagnosis of osteoporosis and other knowledge,
  • (4)satisfaction with care,
  • (5)health related quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strategies Targeting Osteoporosis to Prevent Recurrent Fractures
Official Title  ICMJE Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Fractures
Intervention  ICMJE
  • Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines).
  • Behavioral: Multifaceted intervention
    Educational materials, counseling, opinion leader based guidelines, reminders
  • Other: Usual Care
Study Arms  ICMJE
  • Experimental: A
    Multifaceted intervention
    Interventions:
    • Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines).
    • Behavioral: Multifaceted intervention
  • Active Comparator: B
    Usual Care
    Intervention: Other: Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2008)
242
Original Enrollment  ICMJE
 (submitted: September 7, 2005)
220
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00152321
Other Study ID Numbers  ICMJE University of Alberta
CIHR-MOP #62906
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sumit R. Majumdar, University of Alberta
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Alberta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Sumit R Majumdar, MD, MPH University of Alberta
PRS Account University of Alberta
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP