Clinical trial NCT01104324: Osteonecrosis in Children With Acute Lymphoblastic Leukemia
Official title: Steroid Induced Osteoporosis in the Pediatric Population Ancillary Study- Osteonecrosis in Children With Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteonecrosis
Acute Lymphoblastic Leukemia
Keywords: bone health
Osteonecrosis
acute lymphoblastic leukemia
Lead sponsor: Halton, Jacqueline, M.D.
Sponsor class: OTHER
Collaborators: name: C17 Council
First posted: 2010-04-15
Enrollment: 130
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: osteonecrosis 1 year post leukemia therapy
timeFrame: One year after completion of therapy for leukemia
Secondary outcomes:
measure: Bone mass density and Osteonecrosis
timeFrame: One year post therapy for leukemia
measure: Is Bone loss/failure to accure bone mineral and ON
timeFrame: One year post leukemia therapy
measure: Glucocorticoid dose and ON
timeFrame: One year post Leukemia therapy
measure: Methotrexate dose and ON
timeFrame: One year post leukemia therpy
measure: Obesity and ON
timeFrame: One year post leukemia therapy
measure: Weight bearing and non weight bearing activities and ON
timeFrame: One year post leukrmia therapy
measure: Hyperlipidemia and On
timeFrame: One year post leukemia therapy
measure: Thrombophilia and ON
timeFrame: One year post leukemia therapy
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Children's Hospital
state: Manitoba
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: London
country: Canada
facility: Children's Hospital of Western Ontario
state: Ontario
city: Ottawa
country: Canada
facility: Childrens Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Hopital Sainte-Justine
state: Quebec
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: Childrens Hospital of Easten Ontario
name: Jacqueline Halton
role: PRINCIPAL_INVESTIGATOR
References: