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Osteonecrosis in Children With Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Halton, Jacqueline, M.D..
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
C17 Council
Information provided by:
Halton, Jacqueline, M.D.
ClinicalTrials.gov Identifier:
NCT01104324
First received: April 12, 2010
Last updated: April 14, 2010
Last verified: April 2010
  Purpose
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.

Condition
Osteonecrosis
Acute Lymphoblastic Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Steroid Induced Osteoporosis in the Pediatric Population Ancillary Study- Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Halton, Jacqueline, M.D.:

Primary Outcome Measures:
  • osteonecrosis 1 year post leukemia therapy [ Time Frame: One year after completion of therapy for leukemia ] [ Designated as safety issue: No ]
    Each participant will undergo MRI of hip, knee, ankle and shoulder to look for ON


Secondary Outcome Measures:
  • Bone mass density and Osteonecrosis [ Time Frame: One year post therapy for leukemia ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA
Platlet free plasma

Estimated Enrollment: 130
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104324

Locations
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg Children's Hospital
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
Children's Hospital of Western Ontario
London, Ontario, Canada
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Canada, Quebec
Hopital Sainte-Justine
Montreal, Quebec, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
Halton, Jacqueline, M.D.
C17 Council
Investigators
Principal Investigator: Jacqueline Halton Childrens Hospital of Easten Ontario
  More Information

Responsible Party: Jacqueline Halton MD, Childrens Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01104324     History of Changes
Other Study ID Numbers: 08/20E 
Study First Received: April 12, 2010
Last Updated: April 14, 2010
Health Authority: Canada: CHEO Research Ethics Board

Keywords provided by Halton, Jacqueline, M.D.:
bone health
Osteonecrosis
acute lymphoblastic leukemia

Additional relevant MeSH terms:
Osteonecrosis
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on December 08, 2016