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Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

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ClinicalTrials.gov Identifier: NCT00136058
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : December 16, 2011
Sponsor:
Collaborator:
Alberta Heritage Foundation for Medical Research
Information provided by:
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Procedure: bone densitometry (DEXA) Drug: alendronate or risedronate Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
Study Start Date : January 2002
Estimated Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. the number of patients who get a BMD and the number who are started on active osteoporosis therapy


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136058


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G2S2
Sponsors and Collaborators
University of Alberta
Alberta Heritage Foundation for Medical Research
Investigators
Principal Investigator: Donald W Morrish, MD, PhD University of Alberta

ClinicalTrials.gov Identifier: NCT00136058     History of Changes
Other Study ID Numbers: Hipfracture1
AHFMR 200100791-2
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011

Keywords provided by University of Alberta:
osteoporosis
hip fracture

Additional relevant MeSH terms:
Osteoporosis
Hip Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Alendronate
Risedronate Sodium
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action