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Optimal Management of Women With Wrist Fractures

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00226031
First received: September 22, 2005
Last updated: June 23, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention
Osteoporosis
Osteopenia
 Procedure: Educational Material and Reminder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Optimal Management of Older Women With Distal Forearm Fractures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Proportion of women who are prescribed anti-osteoporosis therapy within 6 months of sustaining a forearm fracture. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Women's knowledge about osteoporosis and fractures (Osteoporosis Knowledge Questionnaire). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: September 2003
Study Completion Date: August 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226031

Locations
Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Ann B Cranney, MD Queen's University
  More Information

No publications provided

Responsible Party: Dr. Ann Cranney, University of Ottawa
ClinicalTrials.gov Identifier: NCT00226031     History of Changes
Other Study ID Numbers: KTS-62358
Study First Received: September 22, 2005
Last Updated: June 23, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
Osteoporosis
Wrist fractures
Knowledge translation
Implementation
Educational reminder

Additional relevant MeSH terms:
Fractures, Bone
Bone Diseases, Metabolic
Osteoporosis
 Wounds and Injuries
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 21, 2013