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Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients - Article


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Osteoporosis

Bone Loss


Clinical Trial: Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

This study has been completed.

Sponsors and Collaborators: University of Alberta
Alberta Heritage Foundation for Medical Research
Information provided by: University of Alberta
ClinicalTrials.gov Identifier: NCT00136058

Purpose

The objective of this study is to determine if an intervention with a fracture manager to arrange bone densitometry after hip fracture is more effective in diagnosing and treating osteoporosis than compared to "usual care". "Usual care" consists of no intervention to arrange BMD testing or therapy other than what normally occurs in the community. We postulate that a fracture manager will be more effective in getting BMD done and in starting appropriate therapy.
Condition Intervention Phase
Osteoporosis
Hip Fracture
 Procedure: bone densitometry (DEXA)
 Drug: alendronate or risedronate
Phase III

MedlinePlus related topics:  Hip Injuries and Disorders;   Osteoporosis

Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study

Further Study Details: 

Expected Total Enrollment:  250

Study start: January 2002;  Study completion: April 2006
Last follow-up: April 2006;  Data entry closure: April 2006

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:

  1. 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.
  2. 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.

Eligibility

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Age 50 or over, male or female
  • 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:

Location Information


Canada, Alberta
      University of Alberta, Edmonton,  Alberta,  T6G2S2,  Canada

Study chairs or principal investigators

Donald W Morrish, MD, PhD,  Principal Investigator,  University of Alberta   

More Information

Study ID Numbers:  Hipfracture1; AHFMR 200100791-2
Last Updated:  August 25, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136058
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30


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