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Strategies Targeting Osteoporosis to Prevent Recurrent Fractures
This study is ongoing, but not recruiting participants.
Study NCT00152321   Information provided by University of Alberta
First Received: September 7, 2005   Last Updated: June 19, 2008   History of Changes

September 7, 2005
June 19, 2008
September 2003
March 2006   (final data collection date for primary outcome measure)
The proportion of patients starting bisphosphonate treatment within 6 months of fracture [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The proportion of patients starting bisphosphonate treatment within 6 months of fracture
Complete list of historical versions of study NCT00152321 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
 
Strategies Targeting Osteoporosis to Prevent Recurrent Fractures
Strategies Targeting Osteoporosis to Prevent Recurrent Fractures (STOP# Study)

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)

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.

 
Interventional
Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
  • Osteoporosis
  • Fractures
  • Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines).
  • Behavioral: Multifaceted intervention
  • Other: Usual Care
  • Experimental: Multifaceted intervention
  • Active Comparator: Usual Care
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
242
March 2009
March 2006   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00152321
Sumit R. Majumdar, University of Alberta
University of Alberta, CIHR-MOP #62906
University of Alberta
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Sumit R Majumdar, MD, MPH University of Alberta
University of Alberta
June 2008

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