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Randomized Controlled Trial
. 2008 Sep;29(5):711-9.
doi: 10.1016/j.cct.2008.05.002. Epub 2008 May 18.

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

Shesh N Rai  1 , Melissa M Hudson, Elizabeth McCammon, Laura Carbone, Francis Tylavsky, Karen Smith, Harriet Surprise, John Shelso, Chin-Hon Pui, Sue Kaste
Affiliations
Randomized Controlled Trial

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

Shesh N Rai et al. Contemp Clin Trials. 2008 Sep.

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.

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BONEII study schema
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