Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01104324
• Other study ID #: 08/20E
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2010
• Last updated: April 14, 2010
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2010
• Source: Halton, Jacqueline, M.D.
• Contact: Jacqueline Halton
• Phone: 613 737 7600
• Is FDA regulated: No
• Health authority: Canada: CHEO Research Ethics Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Osteonecrosis
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Children's Hospital of Western Ontario	London	Ontario
Canada	Hopital Sainte-Justine	Montreal	Quebec
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Childrens Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia
Canada	Winnipeg Children's Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Halton, Jacqueline, M.D.	C17 Council

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No