Recruiting
Phase 3

Aspirin

Sponsor:

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

Code:

NCT03405974

Conditions

Osteonecrosis of Femoral Head

Osteonecrosis; Aseptic, Idiopathic

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Aspirin

Placebo

Study Details

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

Study ID

NCT03405974

Start date

Oct 12, 2017

Status verified date

Jan, 2018

Completion date

Nov 1, 2021

Anticipated

Primary completion date

Nov 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aspirin

Aspirin 100 mg

1 tablet/ day for 2 years

placebo comparator: Placebo

Placebo

1 tablet/ day for 2 years

Interventions

Aspirin

Aspirin (acetylsalicylic acid)

Placebo

Placebo

Primary outcome measure

  • Evaluation of radiologic progression of osteonecrosis [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Principal Investigator:

Chantal Séguin, MD

More Information

Sponsor

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

Last update posted

Jan 24, 2018

Last verified

Jan, 2018

Keywords

  • Osteonecrosis
  • Aspirin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2018-01-24.