CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 429 enrolled
Drug / intervention
Calcium carbonate (Tums), vitamin D +1 moredrug
Likely dose
Calcium carbonate 100 mg/day plus vitamin D 800 units/dayAI-extracted
Key inclusion· 4
  • Survivor of acute lymphoblastic leukemia
  • Treated on St. Jude Children's Research Hospital's Total XI, XII, or XIII treatment protocol
  • At least 5 years post-completion of therapy
  • In first remission
Key exclusion· 5
  • Active disease
  • Pregnant or lactating females
  • Inability to chew and swallow pills
  • Currently taking more than 800 mg supplemental calcium or 800 IU vitamin D

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00186901
NCT00186901Phase 3Completed

Diminished Bone Mineral Density in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL): A Severity-Adapted Clinical Trial

St. Jude Children's Research Hospital·interventional·Posted Sep 16, 2005·Updated May 10, 2017

In Brief

A Phase 3 clinical trial evaluating Calcium carbonate (Tums), vitamin D and Placebo for Leukemia, Lymphoblastic, Acute and Osteoporosis. Completed, enrolled 429 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJul 1, 2000
Primary CompletionJun 1, 2009
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 20.8 years ago

Interventions

Calcium carbonate (Tums), vitamin Ddrug

Calcium carbonate 100mg/day (Tums), vitamin D 800 units/day

Placeboother

Placebo