Optimal Management of Women With Wrist Fractures

March 10, 2015 updated by: Queen's University

Optimal Management of Older Women With Distal Forearm Fractures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Queen's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Postmenopausal women with low trauma distal radius fracture (confirmed by x-ray).
  2. Can be taking Didrocal (etidronate), Miacalcin (calcitonin),or hormone replacement therapy .

Exclusion Criteria:

  1. Women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture).
  2. Significant cognitive impairment (which would preclude them from filling out simple questionnaires).
  3. Women already taking osteoporosis therapy, ie. either Fosamax (alendronate), Actonel (risedronate), or the selective estrogen receptor modulator, Evista (raloxifene).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Usual care.
Procedure: Educational Material and Reminder
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.
Experimental: 2
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.
Procedure: Educational Material and Reminder
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of women who are prescribed anti-osteoporosis therapy within 6 months of sustaining a forearm fracture.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months
Women's knowledge about osteoporosis and fractures (Osteoporosis Knowledge Questionnaire).
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Ann B Cranney, MD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 22, 2005

First Submitted That Met QC Criteria

September 22, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTS-62358

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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