Clinical Trial: Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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

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 Summary:
Sponsor: Halton, Jacqueline, M.D.

Current Primary Outcome: osteonecrosis 1 year post leukemia therapy [ Time Frame: One year after completion of therapy for leukemia ]

Each participant will undergo MRI of hip, knee, ankle and shoulder to look for ON


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bone mass density and Osteonecrosis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Methotrexate dose and ON [ Time Frame: 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 [ Time Frame: 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.
  • Weight bearing and non weight bearing activities and ON [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Halton, Jacqueline, M.D.

Dates:
Date Received: April 12, 2010
Date Started: July 2009
Date Completion: December 2012
Last Updated: April 14, 2010
Last Verified: April 2010