Strategies Targeting Osteoporosis to Prevent Recurrent Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Alberta.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00152321
First received: September 7, 2005
Last updated: June 19, 2008
Last verified: June 2008
  Purpose

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)


Condition Intervention
Osteoporosis
Fractures
Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines).
Behavioral: Multifaceted intervention
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • The proportion of patients starting bisphosphonate treatment within 6 months of fracture [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appropriate care (BMD test performed and treatment if low bone mass) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Bone mineral density testing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Self reported diagnosis of osteoporosis and other knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Satisfaction with care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 242
Study Start Date: September 2003
Estimated Study Completion Date: March 2009
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Multifaceted intervention
Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines). Behavioral: Multifaceted intervention
Educational materials, counseling, opinion leader based guidelines, reminders
Active Comparator: B
Usual Care
Other: Usual Care
Other Name: Usual care

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152321

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Sumit R Majumdar, MD, MPH University of Alberta
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sumit R. Majumdar, University of Alberta
ClinicalTrials.gov Identifier: NCT00152321     History of Changes
Other Study ID Numbers: University of Alberta, CIHR-MOP #62906
Study First Received: September 7, 2005
Last Updated: June 19, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
osteoporosis
wrist fractures
quality improvement
knowledge translation

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 21, 2014