Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

NCT ID: NCT00136058

Last Updated: 2011-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2006-04-30

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.

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.

Conditions

Osteoporosis

Keywords

osteoporosis; hip fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

bone densitometry (DEXA)

Intervention Type: PROCEDURE

alendronate or risedronate

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Heritage Foundation for Medical Research

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Principal Investigators

Donald W Morrish, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

AHFMR 200100791-2

Identifier Type: -

Identifier Source: secondary_id

Hipfracture1

Identifier Type: -

Identifier Source: org_study_id