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Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Primary Purpose

Osteoporosis, Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Allied health professional-run osteoporosis service ("case-management")
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 treatment, osteoporosis testing, hip fracture, quality improvement

Eligibility Criteria

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

Inclusion Criteria: hip fracture patient > 50 years of age able to give consent (or proxy consent available) lives within health region no contraindications to bisphosphonate therapy Exclusion Criteria: refuses to participate or consent dementia or delirium without a proxy consent available nursing home or longterm care pathologic fracture chronic glucocorticoid use already receiving prescription osteoporosis treatment (calcium and vitamin D do not preclude inclusion)

Sites / Locations

  • University of Alberta Hospitals

Outcomes

Primary Outcome Measures

The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture

Secondary Outcome Measures

Proportion of patients taking prescription osteoporosis treatment at 6 months and 12 months
Proportion in receipt of a BMD test at 6 months and 12 months
Proportion still adherent to osteoporosis treatments at 6 months and 12 months
Proportion of patients with recurrent fractures at 6 months and 12 months
Cost effectiveness analyses

Full Information

First Posted
September 9, 2005
Last Updated
September 13, 2006
Sponsor
University of Alberta
Collaborators
Alberta Heritage Foundation for Medical Research, Royal Alexandra Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00175175
Brief Title
Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
Official Title
Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta
Collaborators
Alberta Heritage Foundation for Medical Research, Royal Alexandra Hospital

4. Oversight

5. Study Description

Brief Summary
Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture. We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.
Detailed Description
Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture. We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Hip Fracture
Keywords
osteoporosis treatment, osteoporosis testing, hip fracture, quality improvement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Allied health professional-run osteoporosis service ("case-management")
Primary Outcome Measure Information:
Title
The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture
Secondary Outcome Measure Information:
Title
Proportion of patients taking prescription osteoporosis treatment at 6 months and 12 months
Title
Proportion in receipt of a BMD test at 6 months and 12 months
Title
Proportion still adherent to osteoporosis treatments at 6 months and 12 months
Title
Proportion of patients with recurrent fractures at 6 months and 12 months
Title
Cost effectiveness analyses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hip fracture patient > 50 years of age able to give consent (or proxy consent available) lives within health region no contraindications to bisphosphonate therapy Exclusion Criteria: refuses to participate or consent dementia or delirium without a proxy consent available nursing home or longterm care pathologic fracture chronic glucocorticoid use already receiving prescription osteoporosis treatment (calcium and vitamin D do not preclude inclusion)
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
19177538
Citation
Morrish DW, Beaupre LA, Bell NR, Cinats JG, Hanley DA, Harley CH, Juby AG, Lier DA, Maksymowych WP, Majumdar SR. Facilitated bone mineral density testing versus hospital-based case management to improve osteoporosis treatment for hip fracture patients: additional results from a randomized trial. Arthritis Rheum. 2009 Feb 15;61(2):209-15. doi: 10.1002/art.24097.
Results Reference
derived
PubMed Identifier
19139320
Citation
Majumdar SR, Lier DA, Beaupre LA, Hanley DA, Maksymowych WP, Juby AG, Bell NR, Morrish DW. Osteoporosis case manager for patients with hip fractures: results of a cost-effectiveness analysis conducted alongside a randomized trial. Arch Intern Med. 2009 Jan 12;169(1):25-31. doi: 10.1001/archinte.169.1.25.
Results Reference
derived
PubMed Identifier
17954806
Citation
Majumdar SR, Beaupre LA, Harley CH, Hanley DA, Lier DA, Juby AG, Maksymowych WP, Cinats JG, Bell NR, Morrish DW. Use of a case manager to improve osteoporosis treatment after hip fracture: results of a randomized controlled trial. Arch Intern Med. 2007 Oct 22;167(19):2110-5. doi: 10.1001/archinte.167.19.2110.
Results Reference
derived

Learn more about this trial

Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

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