Osteoporosis Clinical Trial
Official title:
Diminished Bone Mineral Density in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL): A Severity-Adapted Clinical Trial
Research studies have shown that children who are long-term survivors of childhood leukemia
may be at greater risk for early bone loss called osteoporosis. This bone loss may lead to a
greater risk of broken bones and other spine and bone problems. However, researchers still
do not know much about how frequently this long-term side effect may occur and how severe
the problem is.
St. Jude Children's Research Hospital researchers want to determine the frequency and
severity of this side effect. They are also studying whether taking calcium and Vitamin D
supplements can help children at risk for osteoporosis and if certain factors can be
identified -- such as age at diagnosis, cancer treatments, or family history -- that may
increase the chances of having osteoporosis. Researchers will take an x-ray study called
quantitative computed tomography (QCT) to measure bone mineral density (BMD). The BMD is a
measure of bone strength. If a subject's BMD falls below the average, he/she will be
assigned to one of two groups. Subjects will be randomly assigned (like tossing a coin) to
receive calcium and vitamin D pills. The other half will receive placebo pills that look
like the calcium and vitamin D pills.
The main objectives of the study are:
- To estimate, using quantitative computed tomography (QCT), the prevalence of diminished
bone mineral density (BMD) in patients treated with contemporary, protocol-based
multiagent chemotherapy (+cranial irradiation) for childhood acute lymphoblastic
leukemia (ALL).
- To investigate possible risk factors for the development of diminished BMD in patients
treated with contemporary protocol-based therapy for childhood ALL. Factors to be
examined include patient characteristics (age at the time of treatment, gender, race,
body mass index, physical activity and nutritional status, menarchal status, oral
contraceptive use, growth hormone therapy, smoking and alcohol intake, birth weight,
fracture history); treatment effects (intensity of treatment with antimetabolites and
glucocorticoids; history of cranial irradiation); and genetic predisposition (i.e.,
vitamin D and CYP3A4 receptor polymorphism and family history of osteoporosis).
- To evaluate, in a prospective placebo-controlled double-blinded randomized trial, the
effects of vitamin D and calcium supplementation in addition to nutritional counseling
on BMD in patients with BMD scores below the mean for age- and gender-matched controls,
compared to an educational program of nutritional counseling alone.
Secondary Aim
- To evaluate, in a prospective randomized trial, the correlation between BMD as
determined by QCT and BMD as determined by dual energy x-ray absorptiometry (DEXA) in
patients with BMD more than one standard deviation (SD) below the mean for age- and
gender-matched controls.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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