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Nonsteroidal Anti-inflammatory Drug
Aspirin for Osteonecrosis of the Femoral Head
Phase 3
Waitlist Available
Led By Chantal Séguin, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
The purpose of this study is to determine if prolonged administration of low-dose aspirin will prevent the progression of early-stage osteonecrosis of the femoral head and may even reduce the extent of involvement of the femoral head by the necrotic process The design is intended to be parallel group where a total of 114 patients will be randomized in a 1:1 ratio to the treatment (ASA) and the control (Placebo) arms.
Eligible Conditions
- Osteonecrosis of the Femoral Head
- Osteonecrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bone necrosis
Secondary outcome measures
Measure the percentage involvement of the femoral head on MRI.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AspirinExperimental Treatment1 Intervention
Aspirin 100 mg
1 tablet/ day for 2 years
Group II: PlaceboPlacebo Group1 Intervention
Placebo
1 tablet/ day for 2 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylsalicylic acid
FDA approved
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
444 Previous Clinical Trials
159,434 Total Patients Enrolled
Chantal Séguin, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
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