A Severity-Adapted Clinical Trial of Diminished Bone Mineral Density in Acute Lymphoblastic Leukemia Survivors
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
St. Jude Children's Research Hospital
Treatments:
Calcium Calcium Carbonate Calcium, Dietary Ergocalciferols Vitamin D Vitamins