title: 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 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.
authors.affiliation: Department of Bioinformatics and Biostatistics, School of Public Health; and Biostatistics Shared Facility, JG Brown Cancer Center, University of Louisville, KY, USA.
authors.forename: Shesh N
authors.initials: SN
authors.lastname: Rai
authors.forename: Melissa M
authors.initials: MM
authors.lastname: Hudson
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McCammon
authors.forename: Laura
authors.initials: L
authors.lastname: Carbone
authors.forename: Francis
authors.initials: F
authors.lastname: Tylavsky
authors.forename: Karen
authors.initials: K
authors.lastname: Smith
authors.forename: Harriet
authors.initials: H
authors.lastname: Surprise
authors.forename: John
authors.initials: J
authors.lastname: Shelso
authors.forename: Chin-Hon
authors.initials: CH
authors.lastname: Pui
authors.forename: Sue
authors.initials: S
authors.lastname: Kaste
mesh_terms: D015502:Absorptiometry, Photon; D015519:Bone Density; D002118:Calcium; D002648:Child; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009752:Nutritional Status; D010024:Osteoporosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000150:complications* / Q000401:mortality / Q000503:physiopathology; D011446:Prospective Studies; D012307:Risk Factors; D017741:Survivors; D014807:Vitamin D
chemical_list: D014807:Vitamin D; D002118:Calcium