Expired Study
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Los Angeles, California 90027


Purpose:

Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone density by the end of treatment. This can lead to long-term suffering in survivors due to poor bone health. Vitamin D is known to be associated with bone health and previous research has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens over the course of treatment. Researchers have also learned that a relationship exists between both Vitamin D and fat tissue and ALL and fat tissue. In adolescents being treated for ALL as well as in early survivors, this randomized study will therefore examine the effect of Vitamin D and calcium supplementation on correcting Vitamin D insufficiency and on improving bone density in the context of changes in body composition and body fat. Bone density will be measured by a radiology exam called a quantitative computed tomography (or "qCT") while body composition and body fat will be measured by a different radiology exam called a dual energy x-ray absorptiometry (or "DEXA" scan). The study will also examine in depth the relationship between these three elements - Vitamin D insufficiency, obesity, and ALL - and their impact on bone density.


Criteria:

Inclusion Criteria: GROUP A: PATIENTS WITH NEWLY DIAGNOSED ALL: - Are greater than or equal to 10 years of age and less than or equal to 21 years of age at diagnosis of ALL - Have a new diagnosis of untreated ALL classified as "high risk" per NCI criteria (due to being greater than 10 years of age) - Are beginning treatment with a Children's Cancer Group/Children's Oncology Group "high risk" protocol with a 4-drug induction including steroids - Are not pregnant GROUP B: EARLY SURVIVORS OF ALL - Were treated for ALL and remain in first complete remission ("CR1") - Were equal to or greater than 10 years of age and less than or equal to 21 years of age at diagnosis of ALL - Have completed treatment on or as per a Children's Cancer Group/Children's Oncology Group "high risk" protocol between 12 and 48 months prior to enrollment in this study (consisting of a plan for a 4-drug induction including steroids in Induction, Delayed Intensification, and steroid pulses in Maintenance. Steroids are allowed to have been discontinued due to toxicity). - Are not pregnant GROUP C: SIBLINGS OF GROUP A - Are either a full-sibling or a half-sibling of a patient in Group A - Are living at the same residence as the sibling/half-sibling from Group A - Are greater than or equal to 10 years of age and less than or equal to 21 years of age at the time of study entry, and within 3 years of the age diagnosis of ALL in the sibling/half-sibling from Group A - Are on the same Vitamin D supplementation regimen (if any) as the sibling from Group A at the time of his or her diagnosis Exclusion Criteria (ALL GROUPS): - Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with abnormal bone development - Are undergoing treatment with other medicines that affect bones including chronic use of of steroids, bisphosphonate therapy, or Vitamin D at average dose greater than 400IU/day - Have an underlying diseases altering body structure (i.e. missing a limb, severe dysmorphism) or severely affecting mobility (i.e. total or hemiparesis) - Have a history of chemotherapy or radiation for other cancers - Cannot complete the radiology exams/radiology exams uninterpretable (i.e. people with a hip replacement or prosthesis)


NCT ID:

NCT01317940


Primary Contact:

Principal Investigator
Etan Orgel, MD
Children's Hospital Los Angeles


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90027
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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