Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture

Osteoporosis Clinical Trial

Official title:

Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175214
• Other study ID #: AHFMR#2000000389
• Status: Completed
• Phase: N/A
• First received: September 10, 2005
• Last updated: September 10, 2005
• Start date: January 2001
• Est. completion date: January 2005

Study information

• Verified date: September 2005
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The primary objective of this proposed research is to improve the quality of care for patients who present to the Emergency Department with osteoporosis and a fracture of the wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the primary study outcome, and it is defined as starting any one of hormone therapy, a bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist.

The study hypothesis is that a quality improvement intervention (with multiple components that include a notification system for primary care physicians, patient-specific reminders, locally generated treatment guidelines endorsed by opinion leaders, and patient education and counseling) will lead to increased use of proven efficacious osteoporosis treatments in patients eligible for secondary prevention. This hypothesis will be tested by comparing the intervention with usual care controls, in a prospective nonrandomized controlled trial.

Description:

BACKGROUND: Osteoporosis is a progressive condition that causes a loss of bone mass, skeletal fragility, and fractures. Fractures result in pain, disability, deformity, and death. Osteoporosis is a major population health problem affecting 1.4 million Canadians, 25% of women and 12% of men over the age of 50 years. Current guidelines recommend aggressive secondary prevention in patients with osteoporosis who have suffered a fracture, because these patients have as high as a 20% risk of fracture in the following year, and because there are now proven efficacious treatments that can reduce this risk by 40-60%. Nevertheless, recent studies have shown that these patients are under-recognized and under-treated, demonstrating a care gap between evidence-based best practice and usual care. All patients with osteoporotic fractures (i.e., of the hip, vertebrae, or wrist) benefit from treatment. However, patients who present with a wrist fracture may be best suited to an intervention to improve secondary prevention practices, because wrist fractures are “sentinel events” in the natural history of osteoporosis: they are common, easily diagnosed, always present to medical attention, and occur years before the more devastating and costly fractures of the hip and vertebrae.

OBJECTIVES: The primary objective of this study is to improve the quality of care for patients who present to the ED with osteoporosis and a fracture of the wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the primary study outcome, and it is defined as starting any one of hormone replacement therapy, a bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist.

HYPOTHESIS: A quality improvement intervention directed at patients and their primary care physicians will increase the use of proven efficacious osteoporosis treatment. The intervention itself has multiple components that include: a notification system and patient-specific reminders for primary care physicians, locally developed treatment guidelines endorsed by opinion leaders, and patient education and counseling. The study hypothesis will be tested by comparing the intervention to usual care controls, in a prospective nonrandomized controlled trial.

SPECIFIC AIMS: To determine whether the proposed intervention can-

• 1. Increase the use of proven efficacious osteoporosis treatment in patients with a fracture of the wrist,

• 2. Increase appropriate use of bone mineral density testing,

• 3. Increase patients’ knowledge of osteoporosis and satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• age > 50 years

• any closed distal forearm fracture

• discharged home

Exclusion Criteria:

• unwilling or unable to provide consent

• admitted to hospital

• long term care resident

• residence outside Edmonton, Alberta

• unable to read and converse in English

• currently taking prescription osteoporosis treatment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Wrist Fractures

Intervention

Behavioral:
• Multifaceted intervention (patient education, physician guidelines, reminders)

Locations

Country	Name	City	State
Canada	University of Alberta Hospitals	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Heritage Foundation for Medical Research

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Majumdar SR, Rowe BH, Folk D, Johnson JA, Holroyd BH, Morrish DW, Maksymowych WP, Steiner IP, Harley CH, Wirzba BJ, Hanley DA, Blitz S, Russell AS. A controlled trial to increase detection and treatment of osteoporosis in older patients with a wrist fract — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.
Secondary	1. BMD testing
Secondary	2. Osteoporosis diagnosis
Secondary	3. Osteoporosis related knowledge
Secondary	4. Satisfaction
Secondary	5. Generic, Disease Specific, and Function-related QOL
Secondary	6. Falls, falls-related injuries, and fall interventions
Secondary	7. Persistence of effects and generalizability of effects
Secondary	8. 1, 2, 3 year outcomes