Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

This study has been completed.
Sponsor:
Collaborator:
Alberta Heritage Foundation for Medical Research
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00136058
First received: August 25, 2005
Last updated: December 15, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Osteoporosis
Procedure: bone densitometry (DEXA)
Drug: alendronate or risedronate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Resource links provided by NLM:


Further study details as provided by University of Alberta:

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

Estimated Enrollment: 250
Study Start Date: January 2002
Estimated Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00136058     History of Changes
Other Study ID Numbers: Hipfracture1, AHFMR 200100791-2
Study First Received: August 25, 2005
Last Updated: December 15, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
osteoporosis
hip fracture

Additional relevant MeSH terms:
Osteoporosis
Hip Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 18, 2014