Aspirin in the Prevention of Collapse in Osteonecrosis of the Hip

NCT03405974 | Unknown Phase 3

• 1 other identifier: ONFH-ASA2016
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteonecrosis of Femoral Head; Osteonecrosis; Aseptic, Idiopathic

Keywords

Osteonecrosis; Aspirin

Outcome Measures

Primary Outcomes (1)

• Evaluation of radiologic progression of osteonecrosis

  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 Outcomes (1)

• Measure the percentage involvement of the femoral head on MRI.

  6 months

Study Arms (2)

Aspirin

EXPERIMENTAL

Aspirin 100 mg 1 tablet/ day for 2 years

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

Placebo 1 tablet/ day for 2 years

Drug: Placebo

Interventions

Aspirin DRUG

Aspirin (acetylsalicylic acid)

Also known as: acetylsalicylic acid

Aspirin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• A history of hip trauma or surgery affecting the hip involved with early stage osteonecrosis as per criteria above
• Concurrent use of anticoagulants
• Concurrent use of bisphosphonates
• Concurrent use of Aspirin for any reason
• Patients with recent active severe peptic ulcer disease that are not on PPI.
• 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
• Patients who are hypersensitive to ASA, salicylates, or non-steroidal anti-inflammatory drugs
• 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
• Platelets number should be more than 100,000 ( \> 100 x 109 /L)
• Pregnancy. If the patient is not sure whether she may be pregnant or not, a screening for pregnancy should be done.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Related Publications (1)

• Albers A, Carli A, Routy B, Harvey EJ, Seguin 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. doi: 10.1503/cjs.016814.

  PMID: 26011853 BACKGROUND

MeSH Terms

Conditions

Femur Head Necrosis; Osteonecrosis; Infertility

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Chantal Séguin, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bouziane Azeddine, Ph.D.

CONTACT

5149341934; bouziane.azeddine@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematologist-oncologist

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2018
• First Posted: January 23, 2018
• Study Start: October 12, 2017
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)