Osteonecrosis in Children With Acute Lymphoblastic Leukemia

• Conditions: Osteonecrosis; Acute Lymphoblastic Leukemia

• Registration Number: NCT01104324
• Lead Sponsor: Halton, Jacqueline, M.D.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Status Verified: 2010-04
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-14
• Last Update Submitted: 2010-04-14
• Study First Posted: 2010-04-15
• Last Update Posted: 2010-04-15
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
osteonecrosis 1 year post leukemia therapy	One year after completion of therapy for leukemia	Each participant will undergo MRI of hip, knee, ankle and shoulder to look for ON

Secondary Outcome Measures

Name	Time	Method
Methotrexate dose and ON	One year post leukemia therpy	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.
Obesity and ON	One year post leukemia therapy	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.
Bone mass density and Osteonecrosis	One year post therapy for leukemia	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
Is Bone loss/failure to accure bone mineral and ON	One year post leukemia therapy	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
Glucocorticoid dose and ON	One year post Leukemia therapy	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.
Weight bearing and non weight bearing activities and ON	One year post leukrmia therapy	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.
Hyperlipidemia and On	One year post leukemia therapy	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.
Thrombophilia and ON	One year post leukemia therapy	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.

Trial Locations

Locations (10)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Winnipeg Children's Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Children's Hospital of Western Ontario; 🇨🇦 London, Ontario, Canada

Childrens Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Hopital Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada

Montreal Children's Hospital; 🇨🇦 Montreal, Quebec, Canada