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Aspirin in the Prevention of Collapse in Osteonecrosis of the Hip

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ClinicalTrials.gov Identifier: NCT03405974
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Chantal Seguin, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Osteonecrosis of Femoral Head Osteonecrosis; Aseptic, Idiopathic Drug: Aspirin Drug: Placebo Phase 3

Detailed Description:
  1. TRIAL OBJECTIVES The primary objective of this study is to evaluate the radiologic progression of ONFH on either radiographs or MRI. A successful outcome is defined as no difference in ONFH staging according to the Ficat & Arlet or Steinberg classifications at last patient follow-up compared to initial radiological staging. This translates into lack of progression over the course of the study while the natural evolution is progression over time.

    The secondary objective is to evaluate the percentage of involvement of the femoral head on radiographs and/or MRI which measures the extent of the disease. We expect that the extent of the disease will be reduced at 2 years.

  2. STUDY DESIGN AND DURATION This study is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that aims to test the efficacy of the proposed medical intervention (ASA). 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.

All patients presenting to the osteonecrosis clinic of one of the participating centres will be first evaluated by an orthopedic surgeon to confirm the diagnosis of early ONFH on at least one hip. Selected patients will be screened for eligibility according to specific inclusion and exclusion criteria.

Eligible patients who accept to participate in this study will be randomized to either a control arm (placebo) or a treatment arm (Aspirin). Recruited patient will take their assigned treatment daily at breakfast from enrolment and for a minimum of two years They will be followed over a period of 2 years. Evaluations will be taken at baseline and every 6 months (5 visits in total).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that aims to test the efficacy of the proposed medical intervention (ASA). 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Due to the objectives of the study, the identity of ASA and Placebo treatments will not be known to investigators, research staff, or patients. Access to the randomization code will be strictly controlled in order to ensure double-blind administration of study treatments. Packaging and labeling of ASA and Placebo treatments will be identical to maintain the blind.

All of the study drug profiles will be prepared in order to be identical in appearance to preserve the study blinding. The investigator and the subject, as well as all staff involved in the conduct or management of the study will be blinded to which treatment is assigned.

Primary Purpose: Treatment
Official Title: Aspirin (Acetylsalicylic Acid) in the Prevention of Collapse of the Femoral Head in Early-stage Non-traumatic Osteonecrosis: a Two-year Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin

Aspirin 100 mg

1 tablet/ day for 2 years

Drug: Aspirin
Aspirin (acetylsalicylic acid)
Other Name: acetylsalicylic acid

Placebo Comparator: Placebo

Placebo

1 tablet/ day for 2 years

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Evaluation of radiologic progression of osteonecrosis [ Time Frame: 6 months ]
    The primary endpoint is to evaluate the radiologic progression of ONFH by measuring the difference in ONFH staging according to the Ficat & Arlet or Steinberg classifications at last patient follow-up compared to initial radiological staging.


Secondary Outcome Measures :
  1. Measure the percentage involvement of the femoral head on MRI. [ Time Frame: 6 months ]
    The secondary endpoint is to measure evolving extent of involvement of the femoral head on radiographs and/or MRI that measures the extent of the disease.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-60 years old
  2. Patients with early osteonecrosis of the hip as defined above
  3. Diagnosis confirmed within 3 months of the screening visit
  4. Patients accept to take the study medication

Exclusion Criteria:

  1. A history of hip trauma or surgery affecting the hip involved with early stage osteonecrosis as per criteria above
  2. Concurrent use of anticoagulants
  3. Concurrent use of bisphosphonates
  4. Concurrent use of Aspirin for any reason
  5. Patients with recent active severe peptic ulcer disease that are not on PPI.
  6. Patients with advanced osteonecrosis of the hip with signs of collapse or end-stage joint arthritis of the hip that are immediately referred for surgical consultation for THA
  7. Patients who are hypersensitive to ASA, salicylates, or non-steroidal anti-inflammatory drugs
  8. Hepatic impairment (Bilirubin total, AST, ALT > 2-3x upper limit of normal), renal failure (creatinine level above normal with glomerular filtration rate < 45 ml/minute), or congestive heart failure
  9. Platelets number should be more than 100,000 ( > 100 x 109 /L)
  10. Pregnancy. If the patient is not sure whether she may be pregnant or not, a screening for pregnancy should be done.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405974


Contacts
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Contact: Bouziane Azeddine, Ph.D. 5149341934 ext 45543 bouziane.azeddine@mail.mcgill.ca

Locations
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Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Bouziane Azeddine, Ph.D.    5149341934 ext 45543    bouziane.azeddine@mail.mcgill.ca   
Principal Investigator: Chantal Séguin, MD         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Chantal Séguin, MD McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications:
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Responsible Party: Chantal Seguin, Hematologist-oncologist, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03405974     History of Changes
Other Study ID Numbers: ONFH-ASA2016
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Chantal Seguin, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Osteonecrosis
Aspirin
Additional relevant MeSH terms:
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Aspirin
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics