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


Phase 3
N/A
N/A
Not Enrolling
Both
Leukemia, Lymphoblastic, Acute, Osteoporosis

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD)

Outcome Description:

The effect of taking calcium and vitamin D supplements was measured using Quantitative Computed Tomography (QCT) to calculate a QTC Z score. A standardized Z-score was calculated to indicate the difference between the patient's Bone Mineral Density (BMD) and the mean value for age and gender-appropriate controls. Z-scores from 0 to +2 are considered normal, above +2 are considered to be elevated, from 0 to -1 are considered to represent a mild BMD deficit, between -1 and -2 are considered to represent moderate deficits, and below -2 are considered to represent severe deficits.

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Sue C. Kaste, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

BONEII

NCT ID:

NCT00186901

Start Date:

July 2000

Completion Date:

September 2011

Related Keywords:

  • Leukemia, Lymphoblastic, Acute
  • Osteoporosis
  • Bone Density
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Osteoporosis

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Metabolic Bone Center at the University of TennesseeMemphis, Tennessee  38163
Preventive Medicine, University of TennesseeMemphis, Tennessee  38163