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Optimal Management of Women With Wrist Fractures

Primary Purpose

Osteoporosis, Osteopenia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educational Material and Reminder
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, Wrist fractures, Knowledge translation, Implementation, Educational reminder

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postmenopausal women with low trauma distal radius fracture (confirmed by x-ray). Can be taking Didrocal (etidronate), Miacalcin (calcitonin),or hormone replacement therapy . Exclusion Criteria: Women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture). Significant cognitive impairment (which would preclude them from filling out simple questionnaires). Women already taking osteoporosis therapy, ie. either Fosamax (alendronate), Actonel (risedronate), or the selective estrogen receptor modulator, Evista (raloxifene).

Sites / Locations

  • Queen's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Usual care.

Mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the family physician and a letter and educational package for the women.

Outcomes

Primary Outcome Measures

Proportion of women who are prescribed anti-osteoporosis therapy within 6 months of sustaining a forearm fracture.

Secondary Outcome Measures

Proportion of women in whom a bone density scan is ordered and the proportion of women who receive counseling advice about osteoporosis from their family physicians.
Women's knowledge about osteoporosis and fractures (Osteoporosis Knowledge Questionnaire).

Full Information

First Posted
September 22, 2005
Last Updated
March 10, 2015
Sponsor
Queen's University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00226031
Brief Title
Optimal Management of Women With Wrist Fractures
Official Title
Optimal Management of Older Women With Distal Forearm Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Queen's University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effectiveness of a multifaceted intervention (reminder and educational material) in improving the evaluation of osteoporosis follow-up care of post-menopausal women with wrist fractures by their primary care physicians. The intervention is directed at improving the gap in continuity of care between emergency/fracture clinics and family physicians, and reducing knowledge gaps.
Detailed Description
Numerous studies have demonstrated that women with wrist fractures have lower bone mineral density. Despite new guidelines for the care of such women, research has shown that they are not generally evaluated for osteoporosis. This care gap exists although it is known that wrist fractures are an important marker for subsequent fractures, such as a hip fracture, which represents a significant socio-economic burden to society. Comparison: Cluster randomized trial of women and their physicians, both of whom receive educational material and reminder on post fracture osteoporosis evaluation. Comparison is to women and their physicians who receive standard post fracture information. Family practices are randomized to intervention or non-intervention group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
Keywords
Osteoporosis, Wrist fractures, Knowledge translation, Implementation, Educational reminder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Usual care.
Arm Title
2
Arm Type
Experimental
Arm Description
Mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the family physician and a letter and educational package for the women.
Intervention Type
Procedure
Intervention Name(s)
Educational Material and Reminder
Intervention Description
Family practices were randomly assigned to intervention or usual care. The intervention was a mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the GP and a letter and educational package for the women.
Primary Outcome Measure Information:
Title
Proportion of women who are prescribed anti-osteoporosis therapy within 6 months of sustaining a forearm fracture.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of women in whom a bone density scan is ordered and the proportion of women who receive counseling advice about osteoporosis from their family physicians.
Time Frame
6 months
Title
Women's knowledge about osteoporosis and fractures (Osteoporosis Knowledge Questionnaire).
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal women with low trauma distal radius fracture (confirmed by x-ray). Can be taking Didrocal (etidronate), Miacalcin (calcitonin),or hormone replacement therapy . Exclusion Criteria: Women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture). Significant cognitive impairment (which would preclude them from filling out simple questionnaires). Women already taking osteoporosis therapy, ie. either Fosamax (alendronate), Actonel (risedronate), or the selective estrogen receptor modulator, Evista (raloxifene).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann B Cranney, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada

12. IPD Sharing Statement

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Optimal Management of Women With Wrist Fractures

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