Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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Acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. Improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the usual presenting symptom and may become severe requiring surgical decompression or replacement of the affected joint. Long-term effects including arthritis and progressive joint difficulties will not be known for decades. This study aims to determine the risk factors for developing osteonecrosis that will lead to information for earlier detection and prevention. The study will be the basis for future intervention and prevention trials.

Official Title
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Steroid Induced Osteoporosis in the Pediatric Population Ancillary Study- Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Conditions
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Osteonecrosis, Acute Lymphoblastic Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment in the STOPP-CIS study Informed consent of patient or care givers >5 years of age at MRI assessment Exclusion Criteria: Individuals with a history of claustrophobia precluding MRI assessment

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| osteonecrosis 1 year post leukemia therapy | Each participant will undergo MRI of hip, knee, ankle and shoulder to look for ON | One year after completion of therapy for leukemia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mass density and Osteonecrosis | Is reductions in bone mass density at diagnosis of leukemia associated with the development of ON. These patients are a subset of a lagre study where Bone mass is being measured by DEXA. We will be able to access this data to look for bone mass density | One year post therapy for leukemia | 
| Is Bone loss/failure to accure bone mineral and ON | Is bone loss/failure to accrue bone mineral at a normal rate during chemotherapy is/are associated with the development of ON.These patients are a subset of a lagre study where Bone mass is being measured by DEXA. We will be able to access this data to look for bone loss | One year post leukemia therapy | 
| Glucocorticoid dose and ON | Is there a glucocorticoid threshold dose, above which patients are more likely to develop ON. These patients are a subset of a lagre study where glucocorticoid dose is recorded. We will be able to access this data. | One year post Leukemia therapy | 
| Methotrexate dose and ON | Is there a methotrexate threshold dose, above which patients are more likely to develop ON. These patients are a subset of a lagre study where Methotrexate dose is recorded. We will be able to access this data. | One year post leukemia therpy | 
| Obesity and ON | Is obesity either at diagnosis or during therapy associated with ON. These patients are a subset of a larger group in a larger study. They are recording height weight and BMI. We will be able to access this data. | One year post leukemia therapy | 
| Weight bearing and non weight bearing activities and ON | Does weight bearing and non-weight bearing activities play a role in the development of ON. These patients are a subset of a larger study. They are recording these activities. We will be able to use this data. | One year post leukrmia therapy | 
| Hyperlipidemia and On | Is hyperlipidemia associated with the development of ON. Statins (cholesterol lowering medications) have been suggested as a therapeutic intervention to prevent ON. Fasting blood will be tested for lipids at at least one year post chemtherapy. | One year post leukemia therapy | 
| Thrombophilia and ON | Is thrombophilia associated with the development of ON. Blood will be tested at study entry following one year completion of chemotherapy.Blood will be drawn for protein C, protein S, antithrombin, activated protein C resistance, Factor V Leiden, prothrombin gene complex, MTHFR, lupus anticoagulant and antiphospholipid antibodies and Lipoprotein A. | One year post leukemia therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone health, Osteonecrosis, acute lymphoblastic leukemia