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

Primary Purpose

Osteoporosis, Wrist Fractures

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multifaceted intervention (patient education, physician guidelines, reminders)
Sponsored by
University of Alberta
About
Eligibility
Locations
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: 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

Sites / Locations

  • University of Alberta Hospitals

Outcomes

Primary Outcome Measures

Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.

Secondary Outcome Measures

1. BMD testing
2. Osteoporosis diagnosis
3. Osteoporosis related knowledge
4. Satisfaction
5. Generic, Disease Specific, and Function-related QOL
6. Falls, falls-related injuries, and fall interventions
7. Persistence of effects and generalizability of effects
8. 1, 2, 3 year outcomes

Full Information

First Posted
September 10, 2005
Last Updated
September 10, 2005
Sponsor
University of Alberta
Collaborators
Alberta Heritage Foundation for Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00175214
Brief Title
Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture
Official Title
Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta
Collaborators
Alberta Heritage Foundation for Medical Research

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Wrist 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
Single
Allocation
Non-Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Multifaceted intervention (patient education, physician guidelines, reminders)
Primary Outcome Measure Information:
Title
Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.
Secondary Outcome Measure Information:
Title
1. BMD testing
Title
2. Osteoporosis diagnosis
Title
3. Osteoporosis related knowledge
Title
4. Satisfaction
Title
5. Generic, Disease Specific, and Function-related QOL
Title
6. Falls, falls-related injuries, and fall interventions
Title
7. Persistence of effects and generalizability of effects
Title
8. 1, 2, 3 year outcomes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 Hospitals
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15353428
Citation
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 fracture. Ann Intern Med. 2004 Sep 7;141(5):366-73. doi: 10.7326/0003-4819-141-5-200409070-00011.
Results Reference
result
PubMed Identifier
17086470
Citation
Majumdar SR, Johnson JA, Lier DA, Russell AS, Hanley DA, Blitz S, Steiner IP, Maksymowych WP, Morrish DW, Holroyd BR, Rowe BH. Persistence, reproducibility, and cost-effectiveness of an intervention to improve the quality of osteoporosis care after a fracture of the wrist: results of a controlled trial. Osteoporos Int. 2007 Mar;18(3):261-70. doi: 10.1007/s00198-006-0248-1. Epub 2006 Nov 4.
Results Reference
derived

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

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