Aspirin in the Prevention of Collapse in Osteonecrosis of the Hip

January 22, 2018 updated by: Chantal Seguin, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Recruiting
        • Mcgill University Health Centre
        • Contact:
        • Principal Investigator:
          • Chantal Séguin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspirin

Aspirin 100 mg

1 tablet/ day for 2 years
Drug: Aspirin
Aspirin (acetylsalicylic acid)
Other Names:
  • acetylsalicylic acid
Placebo Comparator: Placebo

Placebo

1 tablet/ day for 2 years
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Chantal Séguin, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2017

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

January 14, 2018

First Submitted That Met QC Criteria

January 14, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONFH-ASA2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

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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