- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00136058
Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G2S2
- University of Alberta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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the number of patients who get a BMD and the number who are started on active osteoporosis therapy
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Donald W Morrish, MD, PhD, University of Alberta
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Fractures, Bone
- Wounds and Injuries
- Leg Injuries
- Musculoskeletal Diseases
- Bone Diseases
- Femoral Fractures
- Hip Injuries
- Bone Diseases, Metabolic
- Hip Fractures
- Osteoporosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Alendronate
- Risedronic Acid
Other Study ID Numbers
- Hipfracture1
- AHFMR 200100791-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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