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

Contemporary Clinical Trials

Volumn 29, Issue 5, 2008, Pages 711-719

  Rai, Shesh N ^a   Hudson, Melissa M ^b   McCammon, Elizabeth ^b   Carbone, Laura ^c   Tylavsky, Francis ^c   Smith, Karen ^b   Surprise, Harriet ^b   Shelso, John ^b   Pui, Chin Hon ^b,c   Kaste, Sue ^b,c  

^a UNIVERSITY OF LOUISVILLE   (United States)

^b ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^c UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

Author keywords

Acute lymphoblastic leukemia; Bone loss; Bone mineral density; Childhood cancer survivors; Pediatric leukemia; Repeated measures analysis; Skeletal toxicities

Indexed keywords

ALKALINE PHOSPHATASE; AMINO TERMINAL TELOPEPTIDE; BIOLOGICAL MARKER; CALCIUM CARBONATE; COLECALCIFEROL; OSTEOCALCIN; PLACEBO;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ADULT; ALCOHOL CONSUMPTION; ARTICLE; BONE ATROPHY; BONE DEFECT; BONE DENSITY; BONE MINERALIZATION; BONE TURNOVER; CALCIUM INTAKE; CALCIUM METABOLISM; CANCER SURVIVOR; CHILDHOOD LEUKEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIETARY INTAKE; DISEASE ASSOCIATION; DOUBLE BLIND PROCEDURE; EXERCISE; FEMALE; HUMAN; INTERVENTION STUDY; LIFESTYLE MODIFICATION; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; NUTRITIONAL COUNSELING; OSTEOLYSIS; PHASE 3 CLINICAL TRIAL; PREVALENCE; PROSPECTIVE STUDY; PROTEIN BLOOD LEVEL; PROTEIN URINE LEVEL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK FACTOR; SCHOOL CHILD; SMOKING; VITAMIN SUPPLEMENTATION;

ABSORPTIOMETRY, PHOTON; BONE DENSITY; CALCIUM; CHILD; DIETARY SUPPLEMENTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; LONGITUDINAL STUDIES; MALE; NUTRITIONAL STATUS; OSTEOPOROSIS; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PROSPECTIVE STUDIES; RISK FACTORS; SURVIVORS; VITAMIN D;

EID: 49949112378     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2008.05.002     Document Type: Article

References (48)

1. Kaste S.C., Chesney R.W., Hudson M.M., et al. Bone mineral status during and after therapy of childhood cancer: an increasing population with multiple risk factors for impaired bone health. J Bone Miner Res 14 (1999) 2010-2014
2. Kaste S.C., Jones-Wallace D., Rose S.R., et al. Bone mineral decrements in survivors of childhood acute lymphoblastic leukemia: frequency of occurrence and risk factors for their development. Leukemia 15 (2001) 728-734
3. Kaste S.C., Rai S.N., Fleming K., et al. Changes in bone mineral density in survivors of childhood acute lymphoblastic leukemia. Pediatr Blood Cancer 46 (2006) 77-87
4. Arikoski P., Komulainen J., Riikonen P., et al. Impaired development of bone mineral density during chemotherapy: a prospective analysis of 46 children newly diagnosed with cancer. J Bone Miner Res 14 (1999) 2002-2009
5. Arikoski P., Kroger H., Riikonen P., et al. Disturbance in bone turnover in children with a malignancy at completion of chemotherapy. Med Pediatr Oncol 33 (1999) 455-461
6. Arikoski P., Komulainen J., Riikonen P., et al. Alterations in bone turnover and impaired development of bone mineral density in newly diagnosed children with cancer: a 1-year prospective study. J Clin Endocrinol Metab 84 (1999) 3174-3181
7. Arikoski P., Komulainen J., Voutilainen R., et al. Reduced bone mineral density in long-term survivors of childhood acute lymphoblastic leukemia. J Pediatr Hematol Oncol 20 (1998) 234-240
8. Arikoski P., Voutilainen R., and Kroger H. Bone mineral density in long-term survivors of childhood cancer. J Pediatr Endocrinol Metab 16 Suppl 2 (2003) 343-353
9. van der Sluis I., de Muinck Keizer-Schrama S.M., and van den Heuvel-Eibrink M.M. Bone mineral density in childhood acute lymphoblastic leukemia (ALL) during and after treatment. Pediatr Blood Cancer 43 (2004) 182-183
10. van der Sluis I., van den Heuvel-Eibrink M.M., Hahlen K., et al. Altered bone mineral density and body composition, and increased fracture risk in childhood acute lymphoblastic leukemia. J Pediatr 141 (2002) 204-210
11. van der Sluis I., van den Heuvel-Eibrink M.M., Hahlen K., et al. Bone mineral density, body composition, and height in long-term survivors of acute lymphoblastic leukemia in childhood. Med Pediatr Oncol 35 (2000) 415-420
12. Kaste S.C., Ahn H., Liu T., et al. Bone mineral density deficits in pediatric patients treated for sarcoma. Pediatr Blood Cancer (2007)
13. Kaste S.C. Bone-mineral density deficits from childhood cancer and its therapy. A review of at-risk patient cohorts and available imaging methods. Pediatr Radiol 34 (2004) 373-378
14. Kaste S.C., Shidler T.J., Tong X., et al. Bone mineral density and osteonecrosis in survivors of childhood allogeneic bone marrow transplantation. Bone Marrow Transplant 33 (2004) 435-441
15. Pui C.H., and Evans W.E. Treatment of acute lymphoblastic leukemia. N Engl J Med 354 (2006) 166-178
16. Valdimarsson O., Linden C., Johnell O., et al. Daily physical education in the school curriculum in prepubertal girls during 1 year is followed by an increase in bone mineral accrual and bone width - data from the prospective controlled Malmo pediatric osteoporosis prevention study. Calcif Tissue Int 78 (2006) 65-71
17. Cheng S., Lyytikainen A., Kroger H., et al. Effects of calcium, dairy product, and vitamin D supplementation on bone mass accrual and body composition in 10-12-y-old girls: a 2-y randomized trial. Am J Clin Nutr 82 (2005) 1115-1126
18. Courteix D., Jaffre C., Lespessailles E., and Benhamou L. Cumulative effects of calcium supplementation and physical activity on bone accretion in premenarchal children: a double-blind randomised placebo-controlled trial. Int J Sports Med 26 (2005) 332-338
19. Schneider M., Dunton G.F., Bassin S., et al. Impact of a school-based physical activity intervention on fitness and bone in adolescent females. J Phys Act Health 4 (2007) 17-29
20. Ianc D., Serbescu C., Bembea M., et al. Effects of an exercise program and a calcium supplementation on bone in children: a randomized control trial. Int J Sport Nutr Exerc Metab 16 (2006) 580-596
21. Macdonald H.M., Kontulainen S.A., Khan K.M., and McKay H.A. Is a school-based physical activity intervention effective for increasing tibial bone strength in boys and girls?. J Bone Miner Res 22 (2007) 434-446
22. Bass S.L., Naughton G., Saxon L., et al. Exercise and calcium combined results in a greater osteogenic effect than either factor alone: a blinded randomized placebo-controlled trial in boys. J Bone Miner Res 22 (2007) 458-464
23. DeBar L.L., Ritenbaugh C., Aickin M., et al. Youth: a health plan-based lifestyle intervention increases bone mineral density in adolescent girls. Arch Pediatr Adolesc Med 160 (2006) 1269-1276
24. Winzenberg T., Shaw K., Fryer J., and Jones G. Effects of calcium supplementation on bone density in healthy children: meta-analysis of randomised controlled trials. BMJ 333 (2006) 775
25. Winzenberg T.M., Shaw K., Fryer J., and Jones G. Calcium supplementation for improving bone mineral density in children. Cochrane Database Syst Rev (2006) CD005119
26. Borer K.T. Physical activity in the prevention and amelioration of osteoporosis in women: interaction of mechanical, hormonal and dietary factors. Sports Med 35 (2005) 779-830
27. Ralston S.H., and de Crombrugghe B. Genetic regulation of bone mass and susceptibility to osteoporosis. Genes Dev 20 (2006) 2492-2506
28. Janz K.F., Gilmore J.M., Burns T.L., et al. Physical activity augments bone mineral accrual in young children: The Iowa Bone Development study. J Pediatr 148 (2006) 793-799
29. Wang X., Kammerer C.M., Wheeler V.W., et al. Genetic and environmental determinants of volumetric and areal BMD in multi-generational families of African ancestry: the Tobago Family Health Study. J Bone Miner Res 22 (2007) 527-536
30. Rivera G.K., Raimondi S.C., Hancock M.L., et al. Improved outcome in childhood acute lymphoblastic leukaemia with reinforced early treatment and rotational combination chemotherapy. Lancet 337 (1991) 61-66
31. Evans W.E., Relling M.V., Rodman J.H., et al. Conventional compared with individualized chemotherapy for childhood acute lymphoblastic leukemia. N Engl J Med 338 (1998) 499-505
32. Pui C.H., Mahmoud H.H., Rivera G.K., et al. Early intensification of intrathecal chemotherapy virtually eliminates central nervous system relapse in children with acute lymphoblastic leukemia. Blood 92 (1998) 411-415
33. Pui C.H., Boyett J.M., Rivera G.K., et al. Long-term results of Total Therapy studies 11, 12 and 13A for childhood acute lymphoblastic leukemia at St Jude Children's Research Hospital. Leukemia 14 (2000) 2286-2294
34. Pui C.H., Sandlund J.T., Pei D., et al. Improved outcome for children with acute lymphoblastic leukemia: results of Total Therapy Study XIIIB at St Jude Children's Research Hospital. Blood 104 (2004) 2690-2696
35. Liu A., Boyett J.M., and Xiong X. Sample size calculation for planning group sequential longitudinal trials. Stat Med 19 (2000) 205-220
36. Diggle P., Heagerty P., and Liang K.Y. Analysis of longitudinal data (2002), Oxford University Press
37. Lloyd T., Andon M.B., Rollings N., et al. Calcium supplementation and bone mineral density in adolescent girls. JAMA 270 (1993) 841-844
38. United States Department of Agriculture. Human Nutrition Information Service. Composition of foods: raw, processed, prepared. In: Nutrition Monitoring Division. Washington, DC: U.S. GPO, 1976-1988; 1988.
39. Liu G., and Liang K.Y. Sample size calculations for studies with correlated observations. Biometrics 53 (1997) 937-947
40. Zelen M. The randomization and stratification of patients to clinical trials. J Chronic Dis 27 (1974) 365-375
41. The SAS System V9 (2003), SAS Institute Inc, Cary, NC
42. Wu M.C., and Bailey K.R. Estimation and comparison of changes in the presence of informative right censoring: conditional linear model. Biometrics 45 (1989) 939-955
43. Milliken G.A., and Johnson D.E. Analysis of messy data, Volume 1: Designed experiments (1992), Van Nostrand Reinhold, New York
44. van der Sluis I., and de Muinck Keizer-Schrama S.M. Osteoporosis in childhood: bone density of children in health and disease. J Pediatr Endocrinol Metab 14 (2001) 817-832
45. Szulc P., Seeman E., and Delmas P.D. Biochemical measurements of bone turnover in children and adolescents. Osteoporos Int 11 (2000) 281-294
46. Crofton P.M., and Kelnar C.J. Bone and collagen markers in paediatric practice. Int J Clin Pract 52 (1998) 557-565
47. Crom D.B., Tyc V.L., Rai S.N., et al. Retention of survivors of acute lymphoblastic leukemia in a longitudinal study of bone mineral density. J Child Health Care 10 (2006) 337-350
48. U.S.Department of Agriculture Home and Garden. Food guide pyramid bulletin no. 252 (2005)