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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

Tracking Information
First Submitted Date  ICMJE January 14, 2018
First Posted Date  ICMJE January 23, 2018
Last Update Posted Date January 24, 2018
Actual Study Start Date  ICMJE October 12, 2017
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03405974 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin in the Prevention of Collapse in Osteonecrosis of the Hip
Official Title  ICMJE 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
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Osteonecrosis of Femoral Head
  • Osteonecrosis; Aseptic, Idiopathic
Intervention  ICMJE
  • Drug: Aspirin
    Aspirin (acetylsalicylic acid)
    Other Name: acetylsalicylic acid
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Aspirin

    Aspirin 100 mg

    1 tablet/ day for 2 years

    Intervention: Drug: Aspirin
  • Placebo Comparator: Placebo

    Placebo

    1 tablet/ day for 2 years

    Intervention: Drug: Placebo
Publications * Albers A, Carli A, Routy B, Harvey EJ, Séguin C. Treatment with acetylsalicylic acid prevents short to mid-term radiographic progression of nontraumatic osteonecrosis of the femoral head: a pilot study. Can J Surg. 2015 Jun;58(3):198-205.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2018)
114
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bouziane Azeddine, Ph.D. 5149341934 ext 45543 bouziane.azeddine@mail.mcgill.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03405974
Other Study ID Numbers  ICMJE ONFH-ASA2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chantal Seguin, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chantal Séguin, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP