Calcium and cholecalciferol supplementation provides no added benefit to nutritional counseling to improve bone mineral density in survivors of childhood acute lymphoblastic leukemia (ALL)

Background: We sought to improve lumbar spine bone mineral density (LS-BMD) in long-term survivors of childhood acute lymphoblastic leukemia (ALL) using calcium and cholecalciferol supplementation. Procedure: This double-blind, placebo-controlled trial randomized 275 participants (median age, 17 [9-36.1] years) with age- and gender-specific LS-BMD Z-scores <0 to receive nutritional counseling with supplementation of 1,000mg/day calcium and 800International Unit cholecalciferol or placebo for 2 years. The primary outcome was change in LS-BMD assessed by quantitative computerized tomography (QCT) at 24 months. Linear regression models were employed to identify the baseline risk factors for low LS-BMD and to compare LS-BMD outcomes. Results: Pre-randomization LS-BMD below the mean was associated with male gender (P=0.0024), White race (P=0.0003), lower body mass index (P<0.0001), and cumulative glucocorticoid doses of ≥5,000mg (P=0.0012). One hundred eighty-eight (68%) participants completed the study; 77% adhered to the intervention. Mean LS-BMD change did not differ between survivors randomized to supplements (0.33±0.57) or placebo (0.28±0.56). Participants aged 9-13 years and those 22-35 years had the greatest mean increases in LS-BMD (0.50±0.66 and 0.37±0.23, respectively). Vitamin D insufficiency (serum 25[OH]D <30ng/ml) found in 296 (75%), was not associated with LS-BMD outcomes (P=0.78). Conclusion: Cholecalciferol and calcium supplementation provides no added benefit to nutritional counseling for improving LS-BMD among adolescent and young adult survivors of ALL (93% of whom had LS-BMD Z-scores above the mean at study entry). Pediatr Blood Cancer 2014;61:885-893.