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A Severity-Adapted Clinical Trial of Diminished Bone Mineral Density in Acute Lymphoblastic Leukemia Survivors
This study is ongoing, but not recruiting participants.
Sponsored by: St. Jude Children's Research Hospital
Information provided by: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00186901
  Purpose

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

MedlinePlus related topics: Calcium Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Minerals Osteoporosis
Drug Information available for: Calcium gluconate Vitamin D Ergocalciferol Calcium carbonate
U.S. FDA Resources
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

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • To see if long-term survivors of ALL have bone loss, by using an x-ray study called quantitative computed tomography (QCT). [ Time Frame: Baseline, 12, 24, 36 months ] [ Designated as safety issue: No ]
  • To see if researchers can identify patient factors (such as age at diagnosis or sex), cancer treatments, or family history that may increase the chances of having osteoporosis. [ Time Frame: Baseline up to year 3 ] [ Designated as safety issue: No ]
  • To see if taking vitamin D and calcium can improve bone mineral density (BMD). [ Time Frame: Baseline, 12, 24, 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the bone mineral density scores determined by QCT with those determined by DEXA scan. [ Time Frame: Baseline, 12, 24, 26 months ] [ Designated as safety issue: No ]

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
Other: Placebo
Placebo
1B: Experimental
Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
Drug: Calcium carbonate (Tums), vitamin D
Calcium carbonate 100mg/day (Tums), vitamin D 800 units/day

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is a survivor of acute lymphoblastic leukemia.
  • Patient was treated on St. Jude Children's Research Hospital's Total XI, XII, or XIII treatment protocol.
  • Patient is at least five years out from completion of therapy and is in first remission

Exclusion Criteria:

  • 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
  • Anemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186901

Locations
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
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Sue C. Kaste, D.O. St. Jude Children's Research Hospital
  More Information

St. Jude Children's Research Hospital  This link exits the ClinicalTrials.gov site

Publications:
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

Keywords provided by St. Jude Children's Research Hospital:
Bone Density

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009