Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

December 15, 2011 updated by: University of Alberta

Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

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.

Study Overview

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

Enrollment

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

December 16, 2011

Last Update Submitted That Met QC Criteria

December 15, 2011

Last Verified

December 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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