Hiệu quả của romosozumab ở bệnh nhân loãng xương có nguy cơ gãy xương cao: một nghiên cứu thực tế tại Nhật Bản

Bliuc D, Nguyen ND, Alarkawi D, Nguyen TV, Eisman JA, Center JR (2015) Accelerated bone loss and increased post-fracture mortality in elderly women and men. Osteoporos Int 26:1331–1339 Wade SW, Strader C, Fitzpatrick LA, Anthony MS, O’Malley CD (2014) Estimating prevalence of osteoporosis: examples from industrialized countries. Arch Osteoporos 9:182 Tu KN, Lie JD, Wan CKV, Cameron M, Austel AG, Nguyen JK, Van K, Hyun D (2018) Osteoporosis: a review of treatment options. Pharm Ther 43:92–104 Padhi D, Jang G, Stouch B, Fang L, Posvar E (2011) Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody. J Bone Miner Res 26:19–26 Ominsky MS, Boyce RW, Li X, Ke HZ (2017) Effects of sclerostin antibodies in animal models of osteoporosis. Bone 96:63–75 Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A (2016) Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med 375:1532–1543 Ishibashi H, Crittenden DB, Miyauchi A, Libanati C, Maddox J, Fan M, Chen L, Grauer A (2017) Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis: a phase 2 study. Bone 103:209–215 Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A (2017) Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med 377:1417–1427 Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP et al (2017) Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet 390:1585–1594 Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S (2018) A phase III randomized placebo-controlled trial to evaluate efficacy and safety of romosozumab in men with osteoporosis. J Clin Endocrinol Metab 103:3183–3193 Miyauchi A, Hamaya E, Yang W, Nishi K, Libanati C, Tolman C, Shimauchi J (2021) Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial. J Bone Miner Metab 39:278–288 Kanis JA on behalf of the World Health Organization Scientific Group (2007) Assessment of osteoporosis at the primary healthcare level. Technical Report. World Health Organization Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, UK Orimo H, Nakamura T, Hosoi T, Iki M, Uenishi K, Endo N, Ohta H, Shiraki M, Sugimoto T, Suzuki T, Soen S, Nishizawa Y, Hagino H, Fukunaga M, Fujiwara S (2012) Japanese 2011 guidelines for prevention and treatment of osteoporosis–executive summary. Arch Osteoporos 7:3–20 Donaldson MG, Palermo L, Ensrud KE, Hochberg MC, Schousboe JT, Cummings SR (2012) Effect of alendronate for reducing fracture by FRAX score and femoral neck bone mineral density: the fracture intervention trial. J Bone Miner Res 27:1804–1810 Harvey NC, Kanis JA, Oden A, Burge RT, Mitlak BH, Johansson H, McCloskey EV (2015) FRAX and the effect of teriparatide on vertebral and non-vertebral fracture. Osteoporos Int 26:2677–2684 Kanis JA, Johansson H, Oden A, McCloskey EV (2009) Bazedoxifene reduces vertebral and clinical fractures in postmenopausal women at high risk assessed with FRAX. Bone 44:1049–1054 Kanis JA, Johansson H, Oden A, McCloskey EV (2010) A meta-analysis of the efficacy of raloxifene on all clinical and vertebral fractures and its dependency on FRAX. Bone 47:729–735 Kanis JA, Johansson H, Oden A, McCloskey EV (2011) A meta-analysis of the effect of strontium ranelate on the risk of vertebral and non-vertebral fracture in postmenopausal osteoporosis and the interaction with FRAX(®). Osteoporos Int 22:2347–2355 McCloskey EV, Johansson H, Oden A, Austin M, Siris E, Wang A, Lewiecki EM, Lorenc R, Libanati C, Kanis JA (2012) Denosumab reduces the risk of osteoporotic fractures in postmenopausal women, particularly in those with moderate to high fracture risk as assessed with FRAX. J Bone Miner Res 27:1480–1486 McCloskey EV, Johansson H, Oden A, Harvey NC, Jiang H, Modin S, Fitzpatrick L, Kanis JA (2017) The effect of abaloparatide-sc on fracture risk is independent of baseline FRAX fracture probability: a post hoc analysis of the ACTIVE study. J Bone Miner Res 32:1625–1631 McCloskey EV, Johansson H, Oden A, Vasireddy S, Kayan K, Pande K, Jalava T, Kanis JA (2009) Ten-year fracture probability identifies women who will benefit from clodronate therapy–additional results from a double-blind, placebo-controlled randomised study. Osteoporos Int 20:811–817 McCloskey EV, Johansson H, Harvey NC, Lorentzon M, Shi Y, Kanis JA (2021) Romosozumab efficacy on fracture outcomes is greater in patients at high baseline fracture risk: a post hoc analysis of the first year of the frame study. Osteoporos Int 32:1601–1608 EVENITY Japanese package insert (online). Available from: https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/112292_3999449G1025_2_01. Accessed 23 June 2023 Kobayakawa T, Miyazaki A, Saito M, Suzuki T, Takahashi J, Nakamura Y (2021) Denosumab versus romosozumab for postmenopausal osteoporosis treatment. Sci Rep 11:11801 Kobayakawa T, Suzuki T, Nakano M, Saito M, Miyazaki A, Takahashi J, Nakamura Y (2021) Real-world effects and adverse events of romosozumab in Japanese osteoporotic patients: a prospective cohort study. Bone Rep 14:101068 Tominaga A, Wada K, Okazaki K, Nishi H, Terayama Y, Kato Y (2021) Early clinical effects, safety, and predictors of the effects of romosozumab treatment in osteoporosis patients: one-year study. Osteoporos Int 32:1999–2009 Ebina K, Hirao M, Tsuboi H, Nagayama Y, Kashii M, Kaneshiro S, Miyama A, Nakaya H, Kunugiza Y, Okamura G, Etani Y, Takami K, Goshima A, Nakata K (2020) Effects of prior osteoporosis treatment on early treatment response of romosozumab in patients with postmenopausal osteoporosis. Bone 140:115574 Ebina K, Tsuboi H, Nagayama Y, Kashii M, Kaneshiro S, Miyama A, Nakaya H, Kunugiza Y, Hirao M, Okamura G, Etani Y, Takami K, Goshima A, Miura T, Nakata K, Okada S (2021) Effects of prior osteoporosis treatment on 12-month treatment response of romosozumab in patients with postmenopausal osteoporosis. Joint Bone Spine 88:105219 Shimizu T, Arita K, Murota E, Hiratsuka S, Fujita R, Ishizu H, Asano T, Takahashi D, Takahata M, Iwasaki N (2021) Effects after starting or switching from bisphosphonate to romosozumab or denosumab in Japanese postmenopausal patients. J Bone Miner Metab 39:868–875 Kobayakawa T, Miyazaki A, Takahashi J, Nakamura Y (2022) Verification of efficacy and safety of ibandronate or denosumab for postmenopausal osteoporosis after 12-month treatment with romosozumab as sequential therapy: the prospective VICTOR study. Bone 162:116480 Ebina K, Etani Y, Tsuboi H, Nagayama Y, Kashii M, Miyama A, Kunugiza Y, Hirao M, Okamura G, Noguchi T, Takami K, Goshima A, Miura T, Fukuda Y, Kurihara T, Okada S, Nakata K (2022) Effects of prior osteoporosis treatment on the treatment response of romosozumab followed by denosumab in patients with postmenopausal osteoporosis. Osteoporos Int 33:1807–1813 Japan National Receipt Database Open Data (online). Available from: https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000177221_00003.html. Accessed on 20 June 2023 Soen S, Fukunaga M, Sugimoto T, Sone T, Fujiwara S, Endo N, Gorai I, Shiraki M, Hagino H, Hosoi T, Ohta H, Yoneda T, Tomomitsu T, Japanese Society for Bone Mineral Research and Japan Osteoporosis Society Joint Review Committee for the Revision of the Diagnostic Criteria for Primary Osteoporosis (2013) Diagnostic criteria for primary osteoporosis: year 2012 revision. J Bone Miner Metab 31:247–257 Lenchik L, Rogers LF, Delmas PD, Genant HK (2004) Diagnosis of osteoporotic vertebral fractures: importance of recognition and description by radiologists. AJR Am J Roentgenol 183:949–958 Vasikaran S, Eastell R, Bruyère O, Foldes AJ, Garnero P, Griesmacher A, McClung M, Morris HA, Silverman S, Trenti T, Wahl DA, Cooper C, Kanis JA, Group I-IBMSW (2011) Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos Int 22:391–420 Miyauchi A, Dinavahi RV, Crittenden DB, Yang W, Maddox JC, Hamaya E, Nakamura Y, Libanati C, Grauer A, Shimauchi J (2019) Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension. Arch Osteoporos 14:59 McClung MR, Grauer A, Boonen S, Bolognese MA, Brown JP, Diez-Perez A, Langdahl BL, Reginster JY, Zanchetta JR, Wasserman SM, Katz L, Maddox J, Yang YC, Libanati C, Bone HG (2014) Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med 370:412–420 Cosman F, Kendler DL, Langdahl BL, Leder BZ, Lewiecki EM, Miyauchi A, Rojeski M, McDermott M, Oates MK, Milmont CE, Libanati C, Ferrari S (2022) Romosozumab and antiresorptive treatment: the importance of treatment sequence. Osteoporos Int 33:1243–1256 LeBoff MS, Greenspan SL, Insogna KL, Lewiecki EM, Saag KG, Singer AJ, Siris ES (2022) The clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int 33:2049–2102 Fujiwara S, Miyauchi A, Hamaya E, Nicholls RJ, Weston A, Baidya S, Pinto L, Barron R, Takada J (2018) Treatment patterns in patients with osteoporosis at high risk of fracture in Japan: retrospective chart review. Arch Osteoporos 13:34