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Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00136058
Enrollment
250
Registered
2005-08-26
Start date
2002-01-31
Completion date
2006-04-30
Last updated
2011-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

osteoporosis, hip fracture

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.

Interventions

PROCEDUREbone densitometry (DEXA)
DRUGalendronate or risedronate

Sponsors

Alberta Heritage Foundation for Medical Research
CollaboratorOTHER
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
the number of patients who get a BMD and the number who are started on active osteoporosis therapy

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026