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21 1) van Staa TP, Leufkens HG, Cooper C. The epidemiology of corticosteroid-induced osteoporosis: a meta-analysis. Osteoporos Int 2002; 13: ) van Staa TP, Leufkens HG, Abenhaim L, Zhang B, Cooper C. Oral corticosteroids and fracture risk: relationship to daily and cumulative doses. Rheumatology (Oxford) 2000; 39: ) Kanis JA, Borgstrom F, De Laet C, Johansson H, Johnell O, Jonsson B, et al. Assessment of fracture risk. Osteoporos Int 2005;16: Dalle Carbonare L, Arlot ME, Chavassieux PM, Roux JP, Portero NR, Meunier PJ. Comparison of trabecular bone microarchitecture and remodeling in glucocorticoid-induced and postmenopausal osteoporosis. J Bone Miner Res 2001 ;16: ; 64 : Vogt TM, Ross PD, Palermo L, Musliner T, Genant HK, Black D,at al. Vertebral fracture prevalence among women screened for the Fracture Intervention Trial 20
22 and a simple clinical tool to screen for undiagnosed vertebral fractures. Fracture Intervention Trial Research Group. Mayo Clin Proc 2000 ;75: Manolagas SC, Weinstein RS. New developments in the pathogenesis and treatment of steroid-induced osteoporosis. J Bone Miner Res 1999 ;14: Weinstein RS, Jilka RL, Parfitt AM, Manolagas SC. Inhibition of osteoblastogenesis and promotion of apoptosis of osteoblasts and osteocytes by glucocorticoids. Potential mechanisms of their deleterious effects on bone. J Clin Invest 1998 ;102: Weinstein RS, Chen JR, Powers CC, Stewart SA, Landes RD, Bellido T, et al. Promotion of osteoclast survival and antagonism of bisphosphonate-induced osteoclast apoptosis by glucocorticoids. J Clin Invest 2002;109: Mazziotti G, Angeli A, Bilezikian JP, Canalis E, Giustina A. Glucocorticoid-induced osteoporosis: an update. Trends Endocrinol Metab 2006;17: Walsh LJ, Wong CA, Pringle M, Tattersfield AE. Use of oral corticosteroids in the community and the prevention of secondary osteoporosis: a cross sectional study. BMJ 1996 ;313: Recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. American College of Rheumatology Task Force on Osteoporosis Guidelines. Arthritis Rheum 1996 ;39: ) Nawata H, Soen S, Takayanagi R, Tanaka I, Takaoka K, Fukunaga M, et al. Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and Mineral Research (2004). J Bone Miner Metab 2005;23: ) Adachi JD, Bensen WG, Brown J, Hanley D, Hodsman A, Josse R, et al. Intermittent etidronate therapy to prevent corticosteroid-induced osteoporosis. N Engl J Med 1997; 337: ) Saag KG, Emkey R, Schnitzer TJ, Brown JP, Hawkins F, Goemaere S, et al. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. Glucocoriticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med 1998; 339: ) Cohen S, Levy RM, Keller M, Boling E, Emkey RD, Greenwald M, et al. Risedronate therapy prevents corticosteroid-induced bone loss: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum 1999; 42: ) Reid DM, Hughes RA, Laan RF, Sacco-Gibson NA, Wenderoth DH, Adami S, et al. Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial. European Corticosteroid-Induced Osteoporosis Treatment Study. J Bone Miner Res 2000; 15: ) Adachi JD, Saag KG, Delmas PD, Liberman UA, Emkey RD, Seeman E, et al. Two-year effects of alendronate on bone mineral density and vertebral fracture in patients receiving glucocorticoids: a randomized, double-blind, placebo-controlled extension trial. Arthritis Rheum 2001; 44: ) Sato S, Ohosone Y, Suwa A, Yasuoka H, Nojima T, Fujii T, et al. Effect of intermittent cyclical etidronate therapy on corticosteroid induced osteoporosis in Japanese patients with connective tissue disease: 3 year followup. J 21
23 Rheumatol 2003; 30: ) Nakayamada S, Okada Y, Saito K, Tanaka Y. Etidronate prevents high dose glucocorticoid induced bone loss in premenopausal individuals with systemic autoimmune diseases. J Rheumatol 2004; 31: Osteoporosis Jpn 2007; 15: ) De Nijs RN, Jacobs JW, Algra A, Lems WF, Bijlsma JW. Prevention and treatment of glucocorticoid-induced osteoporosis with active vitamin D 3 analogues: a review with meta-analysis of randomized controlled trials including organ transplantation studies. Osteoporos Int 2004; 15: WHO report technical report 921 Prevention and management of osteoporosis Arai K, Hanyu T,Sugitani H, Murai T, Fujisawa J, Nakazono K, et al. Risk factors for vertebral fracture in menopausal or postmenopausal Japanese women with rheumatoid arthritis:a cross-sectional and longitudinal study. J Bone Miner Metab 2006; 24:
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25 1Osteoporotic fractures secondary to methotrexate of acute leukemia in remission.cancer 25(3) , (5) , Heparin therapy and bone fracture. Lancet 340,1098,1992 5,54(4),2005 6Warfarin Warfarin Use and Risk for Osteoporosis in Elderly Women. Ann.Intern.Med.,128 10,1998 8Risk of Osteoprotic Fracture in Elderly Patients Taking Warfarin. Arch.Intern.Med.,166 Jan, sup3, , ,Med.Pract.16(3):491, Lithium Carbonate Therapy is not a Risk Factor for Osteoporosis.Horm Metab Res,30, ,71: , The bone,10: , ,41: ,
26 1753: , State of arts. 20Tamoxifen and Bone Metabolism in Postmenopausal Low-Risk Brest Cancer Patients J.clin.Oncol.,12, , Results of the ATAC(Arimidex,Tamoxifen,Alone or in Combination)trial completion of 5years adjuvant treatment for breast cancer. Lancet 365, , , Capter 48. Evaluation of postmenopausal osteoporosis American society for bone and mineral reseach,
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31 ICH MedDRA/Jver.11.1 EU ICHICH MedDRA ICH MedDRA/J PT LLT MedDRA MedDRA SMQ SMQ PTPreferred Term) LLTLowest Level Term) PTPreferred Term) LLTLowest Level Term) PTPreferred Term) PTPreferred Term) PTPreferred Term) LLTLowest Level Term) PTPreferred Term) LLTLowest Level Term) PTPreferred Term) PTPreferred Term) Osteoporosis Osteoporosis steroid-induced Bone fragile Osteoporosis, unspecified Osteoporosis NOS Osteoporomalacia Idiopathic osteoporosis Disuse osteoporosis Osteoporotic fracture Osteoporosis with fracture Osteoporotic fracture Senile osteoporosis Osteoporosis postmenopausal Osteoporosis circumscripta cranii Schuller's disease Osteoporosis prophylaxis Prophylaxis against postmenopausal osteoporosis Osteoporosis-pseudoglioma syndrome Post-traumatic osteoporosis 30
6) Weinstein RS, Chen JR, Powers CC, Stewart SA, Landes RD, Bellido T, et al. Promotion of osteoclast survival and antagonism of bisphosphonate-induce
8. 引用文献 参考資料 ) van Staa TP, Leufkens HG, Cooper C. The epidemiology of corticosteroid-induced osteoporosis: a meta-analysis. Osteoporos Int 2002; 3:777-87 2) van Staa TP, Leufkens HG, Abenhaim L, Zhang
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