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Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

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ClinicalTrials.gov Identifier: NCT00175175
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 15, 2006
Sponsor:
Collaborators:
Alberta Heritage Foundation for Medical Research
Royal Alexandra Hospital
Information provided by:
University of Alberta

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date September 15, 2006
Study Start Date  ICMJE March 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • 1. Proportion of patients taking prescription osteoporosis treatment at 6 months and 12 months
  • 2. Proportion in receipt of a BMD test at 6 months and 12 months
  • 3. Proportion still adherent to osteoporosis treatments at 6 months and 12 months
  • 4. Proportion of patients with recurrent fractures at 6 months and 12 months
  • 5. Cost effectiveness analyses
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
Official Title  ICMJE Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Hip Fracture
Intervention  ICMJE Behavioral: Allied health professional-run osteoporosis service ("case-management")
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
220
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00175175
Other Study ID Numbers  ICMJE AHFMR #200100791
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE
  • Alberta Heritage Foundation for Medical Research
  • Royal Alexandra Hospital
Investigators  ICMJE
Principal Investigator: Sumit R Majumdar, MD, MPH University of Alberta
PRS Account University of Alberta
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP