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Clinical Trials/NCT00136058
NCT00136058
Completed
Phase 3

Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

University of Alberta1 site in 1 country250 target enrollmentJanuary 2002

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
University of Alberta
Enrollment
250
Locations
1
Primary Endpoint
the number of patients who get a BMD and the number who are started on active osteoporosis therapy
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The objective of this study is to determine if an intervention with a fracture manager to arrange bone densitometry after a hip fracture is more effective in diagnosing and treating osteoporosis when compared to "usual care". "Usual care" consists of no intervention to arrange bone mineral density (BMD) testing or therapy other than what normally occurs in the community. The investigators postulate that a fracture manager will be more effective in getting BMD done and in starting appropriate therapy.

Detailed Description

All hip fracture patients in the Edmonton area will be screened for eligibility (mini-mental status \>20, not on active osteoporosis pharmacologic therapy). All patients will have informed consent obtained. Patients will be randomized to 2 groups: * Group 1: Active intervention. The fracture manager will arrange for bone densitometry (DEXA) to be done 3-6 months after the fracture. If the patient meets standard criteria for osteoporosis, therapy with a bisphosphonate (alendronate or risedronate) will be instituted by the study physicians. * Group 2: Usual care. Patients will receive basic information about calcium and vitamin D and osteoporosis and told to follow up with their family doctor. At 6 months, patients will be contacted to determine if they have had a BMD done or started on active (drug) osteoporosis therapy. If not, the fracture manager will arrange the BMD and if appropriate therapy will be started by the study physicians. All patients will be followed for 1 year. The primary endpoints are the number of patients who get a BMD and the number who are started on active osteoporosis therapy.

Registry
clinicaltrials.gov
Start Date
January 2002
End Date
April 2006
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Ages 50 or over; males or females.
  • Reside in the community or have access to bone densitometry
  • Hip fracture
  • Patient can consent or proxy consent available
  • No contraindications to bisphosphonates

Exclusion Criteria

  • Patient refuses consent process
  • Already receiving active drug therapy for osteoporosis other than calcium and vitamin D
  • Dementia or delirium
  • Pathological fracture
  • Chronic corticosteroid therapy

Outcomes

Primary Outcomes

the number of patients who get a BMD and the number who are started on active osteoporosis therapy

Study Sites (1)

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