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Effectiveness of monthly intravenous ibandronate on the low responders to oral bisphosphonate: the MOVEMENT study

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Abstract

The MOVEMENT study was designed to assess the effectiveness of monthly intravenous ibandronate on bone mineral density (BMD) in daily clinical practice in Japanese patients with primary osteoporosis whose lumbar spine BMD did not increase despite oral bisphosphonate therapy. This study was a multicenter, prospective, interventional study (52 sites; August 2015 to March 2018). Patients aged ≥ 50 years with primary osteoporosis, evaluated as low responders to oral bisphosphonate treatment for 1–3 years, continued on their existing oral bisphosphonate or switched to monthly intravenous ibandronate (1 mg) for 12 months. The primary endpoint was change in lumbar spine BMD from baseline to 12 months in the intravenous ibandronate group (IV IBN). A total of 240 and 141 patients were enrolled in the IV IBN and oral bisphosphonate groups (OBP), respectively. At 12 months, a significant increase in mean percent change from baseline in lumbar spine BMD was observed in the IV IBN (2.70%). This change was also significant at 6 months (1.92%). Similarly, the change in total hip BMD showed a significant increase at 12 months (0.78%). In the IV IBN, the responder rate, percentage of patient whose change from baseline of lumbar spine BMD has greater than 0%, for lumbar spine BMD was high at both 6 (72.3%, 141/195 patients) and 12 (78.0%, 145/186 patients) months. No new safety concerns were observed in either treatment group. Treatment with intravenous ibandronate significantly increased lumbar spine BMD without any new safety concerns in Japanese patients with osteoporosis who showed low response to existing oral bisphosphonates.

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  • 27 July 2019

    In the original publication of the article, the Figures 2 and 3 were published incorrectly. The corrected figures are given below,

References

  1. Black DM, Rosen CJ (2016) Clinical practice. Postmenopausal osteoporosis. N Engl J Med 374:254–262

    Article  CAS  Google Scholar 

  2. Hagino H (2015) Bisphosphonate. Nihon Rinsho 73:1683–1689 (Article in Japanese)

    PubMed  Google Scholar 

  3. Camacho PM, Petak SM, Binkley N, Clarke BL, Harris ST, Hurley DL, Kleerekoper M, Lewiecki EM, Miller PD, Narula HS, Pessah-Pollack R, Tangpricha V, Wimalawansa SJ, Watts NB (2016) American association of clinical endocrinologists and American college of endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis -2016-Executive summary. Endocr Pract 22:1111–1118

    Article  Google Scholar 

  4. Qaseem A, Forciea MA, McLean RM, Denberg TD, Clinical guidelines committee of the American College of Physicians (2017) Treatment of low bone density or osteoporosis to prevent fractures in men and women: a clinical practice guideline update from the American College of Physicians. Ann Intern Med 166:818–839

    Article  Google Scholar 

  5. Compston J, Cooper A, Cooper C, Gittoes N, Gregson C, Harvey N, Hope S, Kanis JA, McCloskey EV, Poole KES, Reid DM, Selby P, Thompson F, Thurston A, Vine N, National Osteoporosis Guideline Group (NOGG) (2017) UK clinical guideline for the prevention and treatment of osteoporosis. Arch Osteoporos 12:43

    Article  CAS  Google Scholar 

  6. Japan osteoporosis society (2015) Guidelines—prevention and treatment of osteoporosis 2015 edition. http://www.josteo.com/ja/guideline/. Accessed 7 Aug 2018

  7. Barrett J, Worth E, Bauss F, Epstein S (2004) Ibandronate: a clinical pharmacological and pharmacokinetic update. J Clin Pharmacol 44:951–965

    Article  CAS  Google Scholar 

  8. Porras AG, Holland SD, Gertz BJ (1999) Pharmacokinetics of alendronate. Clin Pharmacokinet 36:315–328

    Article  CAS  Google Scholar 

  9. Sebba AI (2008) Significance of a decline in bone mineral density while receiving oral bisphosphonate treatment. Clin Ther 30:443–452

    Article  CAS  Google Scholar 

  10. Diez-Perez A, Adachi JD, Agnusdei D, Bilezikian JP, Compston JE, Cummings SR, Eastell R, Eriksen EF, Gonzalez-Macias J, Liberman UA, Wahl DA, Seeman E, Kanis JA, Cooper C, IOF CSA Inadequate responders working group (2012) Treatment failure in osteoporosis. Osteoporos Int 23:2769–2774

    Article  CAS  Google Scholar 

  11. Ohta H, Solanki J (2015) Incorporating bazedoxifene into the treatment paradigm for postmenopausal osteoporosis in Japan. Osteoporos Int 26(3):849–863

    Article  CAS  Google Scholar 

  12. Nakamura T, Ito M, Hashimoto J, Shinomiya K, Asao Y, Katsumata K, Hagino H, Inoue T, Nakano T, Mizunuma H, MOVEST Study Group (2015) Clinical efficacy and safety of monthly oral ibandronate 100 mg versus monthly intravenous ibandronate 1 mg in Japanese patients with primary osteoporosis. Osteoporos Int 26:2685–2693

    Article  CAS  Google Scholar 

  13. Nakamura T, Nakano T, Ito M, Hagino H, Hashimoto J, Tobinai M, Mizunuma H, MOVER Study Group (2013) Clinical efficacy on fracture risk and safety of 0.5 mg or 1 mg/month intravenous ibandronate versus 2.5 mg/day oral risedronate in patients with primary osteoporosis. Calcif Tissue Int 93:137–146

    Article  CAS  Google Scholar 

  14. Hagino H, Yoshida S, Hashimoto J, Matsunaga M, Tobinai M, Nakamura T (2014) Increased bone mineral density with monthly intravenous ibandronate contributes to fracture risk reduction in patients with primary osteoporosis: 3-year analysis of the MOVER study. Calcif Tissue Int 95:557–563

    Article  CAS  Google Scholar 

  15. Takeuchi Y, Hashimoto J, Nishida Y, Yamagiwa C, Tamura T, Atsumic A (2018) Safety and effectiveness of monthly intravenous ibandronate injections in a prospective, postmarketing, and observational study in Japanese patients with osteoporosis. Osteoporos Sarcopenia 4:22–28

    Article  Google Scholar 

  16. Kamimura M, Nakamura Y, Ikegami S, Uchiyama S, Kato H, Taguchi A (2017) Significant improvement of bone mineral density and bone turnover markers by denosumab therapy in bisphosphonate-unresponsive patients. Osteoporos Int 28:559–566

    Article  CAS  Google Scholar 

  17. 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 and 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

    Article  Google Scholar 

  18. Lewiecki EM (2010) Bisphosphonates for the treatment of osteoporosis: insights for clinicians. Ther Adv Chronic Dis 1:115–128

    Article  CAS  Google Scholar 

  19. Rizzoli R, Reginster JY, Boonen S, Bréart G, Diez-Perez A, Felsenberg D, Kaufman JM, Kanis JA, Cooper C (2011) Adverse reactions and drug–drug interactions in the management of women with postmenopausal osteoporosis. Calcif Tissue Int 89:91–104

    Article  CAS  Google Scholar 

  20. Bae SJ, Kim BJ, Lim KH, Lee SH, Kim HK, Kim GS, Koh JM (2012) Efficacy of intravenously administered ibandronate in postmenopausal Korean women with insufficient response to orally administered bisphosphonates. J Bone Miner Metab 30:588–595

    Article  CAS  Google Scholar 

  21. Recknor C, Czerwinski E, Bone HG, Bonnick SL, Binkley N, Palacios S, Moffett A, Siddhanti S, Ferreira I, Ghelani P, Wagman RB, Hall JW, Bolognese MA, Benhamou CL (2013) Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy: a randomized open-label trial. Obstet Gynecol 121:1291–1299

    Article  CAS  Google Scholar 

  22. Jofre MP, Askari AD, Hong R (2010) Bisphosphonate nonresponders and the role of compliance. J Clin Densitom 13:122

    Article  Google Scholar 

  23. Lewiecki EM (2003) Nonresponders to osteoporosis therapy. J Clin Densitom 6:307–314

    Article  Google Scholar 

  24. Nakano T, Yamamoto M, Hashimoto J, Tobinai M, Yoshida S, Nakamura T (2016) Higher response with bone mineral density increase with monthly injectable ibandronate 1 mg compared with oral risedronate in the MOVER study. J Bone Miner Metab 34:678–684

    Article  CAS  Google Scholar 

  25. Sakai A, Ikeda S, Okimoto N, Matsumoto H, Teshima K, Okazaki Y, Fukuda F, Arita S, Tsurukami H, Nagashima M, Yoshioka T (2014) Clinical efficacy and treatment persistence of monthly minodronate for osteoporotic patients unsatisfied with, and shifted from, daily or weekly bisphosphonates: the BP-MUSASHI study. Osteoporos Int 25:2245–2253

    Article  CAS  Google Scholar 

  26. Durden E, Pinto L, Lopez-Gonzalez L, Juneau P, Barron R (2017) 2-year persistence and compliance with osteoporosis therapies among postmenopausal women in a commercially insured population in the United States. Arch Osteoporos 12:22

    Article  Google Scholar 

  27. Kishimoto H, Maehara M (2015) Compliance and persistence with daily, weekly, and monthly bisphosphonates for osteoporosis in Japan: analysis of data from the CISA. Arch Osteoporos 10:231

    Article  Google Scholar 

  28. Naylor KE, Bradburn M, Paggiosi MA, Gossiel F, Peel NFA, McCloskey EV, Walsh JS, Eastell R (2018) Effects of discontinuing oral bisphosphonate treatments for postmenopausal osteoporosis on bone turnover markers and bone density. Osteoporos Int 29:1407–1417

    Article  CAS  Google Scholar 

  29. Nancollas GH, Tang R, Phipps RJ, Henneman Z, Gulde S, Wu W, Mangood A, Russell RG, Ebetino FH (2006) Novel insights into actions of bisphosphonates on bone: differences in interactions with hydroxyapatite. Bone 38:617–627

    Article  CAS  Google Scholar 

  30. Paggiosi MA, Peel N, McCloskey E, Walsh JS, Eastell R (2014) Comparison of the effects of three oral bisphosphonate therapies on the peripheral skeleton in postmenopausal osteoporosis: the TRIO study. Osteoporos Int 25:2729–2741

    Article  CAS  Google Scholar 

  31. Emkey R, Delmas PD, Bolognese M, Borges JL, Cosman F, Ragi-Eis S, Recknor C, Zerbini CA, Neate C, Sedarati F, Epstein S (2009) Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): Additional results from the monthly oral therapy with ibandronate for osteoporosis intervention (MOTION) study. Clin Ther 31:751–761

    Article  CAS  Google Scholar 

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Acknowledgements

The authors would like to acknowledge Tatsushi Tomomitsu for his contribution as a member of adjudication committee on DXA data and Akihiro Hirakawa for statistical analysis. The authors acknowledge the co-investigators of the MOVEMENT study group: Fumihiro Oha, Junichi Takada, Takato Kanabuchi, Yasuo Goto, Norimune Taki, Keisuke Hiratsuka, Keiji Sato, Hiroshi Watanabe, Masakazu Tazaki, Sanshiro Hashimoto, Yoshiro Miyasaka, Mizue Tanaka, Yasumasa Ozawa, Manabu Nakayama, Osamu Kaneko, Noriaki Yamamoto, Tadashi Terasaki, Yoshiro Yonezawa, Chikara Kubota, Hidefumi Koiwai, Akira Tsuchikane, Hiroyuki Ohbayashi, Mitsukazu Ishii, Takashi Sato, Masako Miura, Koichi Narikawa, Yoshiaki Osaka, Kenichiro Nakai, Tomoyuki Onishi, Hidenobu Fukunishi, Masako Hayashibara, Katsushi Shigemasa, Kei Takeuchi, Masato Nagashima, Shigeki Nishida, Kitau Teshima, Yuichi Okazaki, Taisei Matsumoto, Satoshi Masuda, Fumio Fukuda, Yoshiharu Esaki, Shinobu Arita, Satoshi Nishida, Kaneyuki Tsuchimochi, Makoto Kawasaki, Yoshihisa Inada, Saburo Matsubara, Yuichi Sakai, and Hidehiro Matsumoto. This study was funded by Chugai Pharmaceutical Co., Ltd. The conduct of this study, including statistical analysis and medical writing, was supported by Mebix, Inc. and funded by Chugai Pharmaceutical Co., Ltd. Third-party medical writing services were provided by Mami Hirano, MS, of Cactus Communications and funded by Chugai Pharmaceutical Co., Ltd.

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Authors

Contributions

HH designed the study and wrote the initial draft of the manuscript. Other authors have contributed to data collection and interpretation, and critically reviewed the manuscript. All authors contributed to analysis and interpretation of data, approved the final version of the manuscript, and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Hiroshi Hagino.

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Conflict of interest

H Hagino reports personal fees from Chugai Pharmaceutical Co., Ltd., during the conduct of the study; grants and other from Asahi Kasei Pharma Corp., Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Corp., MSD K.K., Ono Pharmaceutical Co., Ltd., Pfizer Inc., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Co., Ltd. and Daiichi Sankyo Co., Ltd.; and other from Eli Lilly Japan K.K., outside the submitted work. A. Sakai received research grants from Astellas Pharma Inc., Asahi Kasei Pharma Corp., Eisai Co., Ltd., Daiichi Sankyo Co., Ltd., Teijin Pharma Ltd., Chugai Pharmaceutical Co., Ltd., and MSD K.K., and lecture fees from Asahi Kasei Corp., Chugai Pharmaceutical Co., Ltd., and Taisho Toyama Pharmaceutical Co., Ltd., outside the submitted work. Y. Imanishi reports grants from Chugai Pharmaceutical Co., Ltd., during the conduct of the study; personal fees from Chugai Pharmaceutical Co., Ltd., outside the submitted work. H. Tsurukami reports personal fees from Chugai Pharmaceutical Co., Ltd., during the conduct of the study, and personal fees from Eli Lilly Japan K.K., outside the submitted work. S. Ikeda, S. Nakajo, and N. Miyakoshi have nothing to disclose.

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Hagino, H., Sakai, A., Ikeda, S. et al. Effectiveness of monthly intravenous ibandronate on the low responders to oral bisphosphonate: the MOVEMENT study. J Bone Miner Metab 37, 1013–1023 (2019). https://doi.org/10.1007/s00774-019-01005-z

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