Steroid Induced Osteoporosis in the Pediatric Population Ancillary Study- Osteonecrosis in Children With Acute Lymphoblastic Leukemia
| Registry | NCT01104324 |
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| Status | Unknown |
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| Study type | Observational |
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| Enrollment | 130 (Estimated) |
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| Sponsor | Halton, Jacqueline, M.D. (Other); collaborators: C17 Council |
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| Conditions | Osteonecrosis, Acute Lymphoblastic Leukemia |
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| Dates | start 2009-07-01, primary completion 2012-12-01 (estimated), completion 2012-12-01 (estimated), first posted 2010-04-15, last updated 2010-04-15 |
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| Locations | 10 sites in Canada |
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Related Papers Related Patents Related Grants Related Experts
All trials for Osteonecrosis All trials for Acute Lymphoblastic Leukemia
-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.
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+Outcome measures
Primary outcomes
- 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 outcomes
- 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.
- 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.
- 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.
+Eligibility
Sex: All, ages: 5 Years to 18 Years
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
+Locations (10)
| Facility | City | Country | Status |
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| Alberta Children's Hospital | Calgary, Alberta | Canada | Not yet recruiting |
| Stollery Children's Hospital | Edmonton, Alberta | Canada | Not yet recruiting |
| BC Children's Hospital | Vancouver, British Columbia | Canada | Not yet recruiting |
| Winnipeg Children's Hospital | Winnipeg, Manitoba | Canada | Not yet recruiting |
| IWK Health Centre | Halifax, Nova Scotia | Canada | Not yet recruiting |
| Children's Hospital of Western Ontario | London, Ontario | Canada | Not yet recruiting |
| Childrens Hospital of Eastern Ontario | Ottawa, Ontario | Canada | Recruiting |
| Hospital for Sick Children | Toronto, Ontario | Canada | Not yet recruiting |
| Hopital Sainte-Justine | Montreal, Quebec | Canada | Not yet recruiting |
| Montreal Children's Hospital | Montreal, Quebec | Canada | Not yet recruiting |
+Investigators