Implementing an intervention to improve bone mineral density in survivors of childhood acute lymphoblastic leukemia: BONEII, a prospective placebo-controlled double-blind randomized interventional longitudinal study design

Abstract The BONEII study is a large two-phase study. The baseline study (Study 1) aims to estimate the prevalence of diminished bone mineral density (BMD) in patients treated for childhood acute lymphoblastic leukemia (ALL) and identify risk factors for BMD deficits. The interventional phase (Study...

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Bibliographic Details
Published in:Contemporary clinical trials 2008-09, Vol.29 (5), p.711-719
Main Authors: Rai, Shesh N, Hudson, Melissa M, McCammon, Elizabeth, Carbone, Laura, Tylavsky, Francis, Smith, Karen, Surprise, Harriet, Shelso, John, Pui, Chin-Hon, Kaste, Sue
Format: Article
Language:English
Subjects:
Absorptiometry, Photon
Acute lymphoblastic leukemia
Biological and medical sciences
Bone Density
Bone loss
Bone mineral density
Calcium
Cardiovascular
Child
Childhood cancer survivors
Dietary Supplements
Diseases of the osteoarticular system
Double-Blind Method
Female
Hematologic and hematopoietic diseases
Hematology, Oncology and Palliative Medicine
Humans
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
Longitudinal Studies
Male
Medical sciences
Nutritional Status
Osteoporosis - diagnosis
Osteoporosis - etiology
Osteoporosis - prevention & control
Osteoporosis. Osteomalacia. Paget disease
Pediatric leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma - complications
Precursor Cell Lymphoblastic Leukemia-Lymphoma - mortality
Precursor Cell Lymphoblastic Leukemia-Lymphoma - physiopathology
Prospective Studies
Repeated measures analysis
Risk Factors
Skeletal toxicities
Survivors
Vitamin D
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Summary:Abstract The BONEII study is a large two-phase study. The baseline study (Study 1) aims to estimate the prevalence of diminished bone mineral density (BMD) in patients treated for childhood acute lymphoblastic leukemia (ALL) and identify risk factors for BMD deficits. The interventional phase (Study 2) of BONEII has a placebo-controlled double-blind randomized longitudinal design to evaluate the effects of nutritional counseling and calcium and vitamin D supplementation on changes in BMD and serum and urine markers of bone metabolism. The extensive information being collected through this large study will serve as a repository of relational data about BMD and bone turnover and will support further investigations to assess the association of calcium metabolism, bone turnover, nutritional intake, lifestyle factors (such as exercise and the use of alcohol and tobacco), and the specific agents used in ALL therapy in this rapidly increasing population of childhood cancer survivors.
ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2008.05.002