Optimal Management of Women With Wrist Fractures

Osteoporosis Clinical Trial

Official title:

Optimal Management of Older Women With Distal Forearm Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226031
• Other study ID #: KTS-62358
• Status: Completed
• Phase: N/A
• First received: September 22, 2005
• Last updated: March 10, 2015
• Start date: September 2003
• Est. completion date: August 2007

Study information

• Verified date: March 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: August 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

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.

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women who are prescribed anti-osteoporosis therapy within 6 months of sustaining a forearm fracture.		6 months	No
Secondary	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.		6 months	No
Secondary	Women's knowledge about osteoporosis and fractures (Osteoporosis Knowledge Questionnaire).		6 months	No