Osteonecrosis in Children With Acute Lymphoblastic Leukemia

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Lymphoblastic Leukemia; Osteonecrosis

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: Jacqueline Halton; Phone Number: 2978 613 737 7600
• Study Contact Backup: Name: Lynda Hoey; Phone Number: 4109 613 737 7600

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Not yet recruiting
      • Alberta Children's Hospital
      • Contact: Julie Hamilton; Phone Number: 403 955 7641
    • Edmonton, Alberta, Canada
      • Not yet recruiting
      • Stollery Children's Hospital
      • Contact: Linda Churcher; Phone Number: 780 407 8790
      • Principal Investigator: Bev Wilson, MD
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Not yet recruiting
      • BC Children's Hospital
      • Contact: Terry Viczko; Phone Number: 5312 604 875 2345
      • Principal Investigator: David Dix, MD
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Not yet recruiting
      • Winnipeg Children'S Hospital
      • Contact: Dan Catte; Phone Number: 204 977 5645
      • Principal Investigator: Sara Israels, MD
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Not yet recruiting
      • IWK Health Centre
      • Contact: Alesha Warner; Phone Number: 902 470-7414
      • Principal Investigator: Beth Cummings, MD
  • Ontario
    • London, Ontario, Canada
      • Not yet recruiting
      • Children's Hospital of Western Ontario
      • Contact: Martha Rolland
      • Principal Investigator: Beth Cairney, MD
    • Ottawa, Ontario, Canada
      • Recruiting
      • Childrens Hospital of Eastern Ontario
      • Contact: MacLennan; Phone Number: 613 737 7600
      • Principal Investigator: Jacqueline Halton, MD
      • Sub-Investigator: Leanne Ward, MD
    • Toronto, Ontario, Canada
      • Not yet recruiting
      • Hospital for Sick Children
      • Principal Investigator: Ron Grant
  • Quebec
    • Montreal, Quebec, Canada
      • Not yet recruiting
      • Hopital Sainte-Justine
      • Contact: Claude Belleville; Phone Number: 2579 (514) 345-4931
      • Principal Investigator: Nathalie Alos, MD
    • Montreal, Quebec, Canada
      • Not yet recruiting
      • Montreal Children's Hospital
      • Contact: Diane Laforte; Phone Number: 22521 (514) 412-4400
      • Principal Investigator: Celia Rodd, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Acute lymphoblastic leukemia who have participated in the STOPP - CIS study will be eligible for this ancillary study.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Halton, Jacqueline, M.D.
• Collaborators: C17 Council
• Investigators: Principal Investigator: Jacqueline Halton, Childrens Hospital of Easten Ontario

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 14, 2010
• First Posted (ESTIMATE): April 15, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 15, 2010
• Last Update Submitted That Met QC Criteria: April 14, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: acute lymphoblastic leukemia; Osteonecrosis; bone health
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Musculoskeletal Diseases; Bone Diseases; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Osteonecrosis
• Other Study ID Numbers: 08/20E