- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00175175
Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- University Of Alberta Hospitals
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture
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Secondary Outcome Measures
Outcome Measure |
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Proportion of patients taking prescription osteoporosis treatment at 6 months and 12 months
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Proportion in receipt of a BMD test at 6 months and 12 months
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Proportion still adherent to osteoporosis treatments at 6 months and 12 months
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Proportion of patients with recurrent fractures at 6 months and 12 months
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Cost effectiveness analyses
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sumit R Majumdar, MD, MPH, University of Alberta
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHFMR #200100791
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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