Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Osteoporosis Clinical Trial

Official title:

Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136058
• Other study ID #: Hipfracture1
• Secondary ID: AHFMR 200100791-
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: December 15, 2011
• Start date: January 2002
• Est. completion date: April 2006

Study information

• Verified date: December 2011
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hip Fractures
• Osteoporosis

Intervention

Procedure:
• bone densitometry (DEXA)

Drug:
• alendronate or risedronate

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Heritage Foundation for Medical Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of patients who get a BMD and the number who are started on active osteoporosis therapy