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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00186901 |
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.
Condition | Intervention | Phase |
---|---|---|
Leukemia, Lymphoblastic, Acute Osteoporosis |
Drug: Calcium carbonate (Tums), vitamin D Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Diminished Bone Mineral Density in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL): A Severity-Adapted Clinical Trial |
Enrollment: | 613 |
Study Start Date: | July 2000 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1A: Placebo Comparator
Nutritional counseling + placebo
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Other: Placebo
Placebo
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1B: Experimental
Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
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Drug: Calcium carbonate (Tums), vitamin D
Calcium carbonate 100mg/day (Tums), vitamin D 800 units/day
|
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 | |
Metabolic Bone Center at the University of Tennessee | |
Memphis, Tennessee, United States, 38163 | |
Preventive Medicine, University of Tennessee | |
Memphis, Tennessee, United States, 38163 |
Principal Investigator: | Sue C. Kaste, D.O. | St. Jude Children's Research Hospital |
Responsible Party: | St.Jude Children's Research Hospital ( Sue C. Kaste, D.O./ Principal Investigator ) |
Study ID Numbers: | BONEII |
Study First Received: | September 12, 2005 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00186901 |
Health Authority: | United States: Institutional Review Board |
Bone Density |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Ergocalciferols Osteoporosis Bone Diseases, Metabolic Calcium Carbonate Bone Diseases |
Calcium, Dietary Leukemia Lymphatic Diseases Vitamin D Musculoskeletal Diseases Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Growth Substances Vitamins |
Physiological Effects of Drugs Bone Density Conservation Agents Antacids Micronutrients Pharmacologic Actions |