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
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