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.
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.
Rai
Shesh N
SN
Department of Bioinformatics and Biostatistics, School of Public Health; and Biostatistics Shared Facility, JG Brown Cancer Center, University of Louisville, KY, USA.
Hudson
Melissa M
MM
McCammon
Elizabeth
E
Carbone
Laura
L
Tylavsky
Francis
F
Smith
Karen
K
Surprise
Harriet
H
Shelso
John
J
Pui
Chin-Hon
CH
Kaste
Sue
S
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
D014807:Vitamin D; D002118:Calcium