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Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Information source: University of Alberta
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: bone densitometry (DEXA) (Procedure); alendronate or risedronate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Alberta

Official(s) and/or principal investigator(s):
Donald W Morrish, MD, PhD, Principal Investigator, Affiliation: University of Alberta

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.

Clinical Details

Official title: Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

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

Primary outcome: the number of patients who get a BMD and the number who are started on active osteoporosis 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.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Alberta, Edmonton, Alberta T6G2S2, Canada
Additional Information

Starting date: January 2002
Last updated: December 15, 2011

Page last updated: August 20, 2015

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