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Journal of Bone and Mineral Metabolism

, Volume 37, Issue 6, pp 1013–1023 | Cite as

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

  • Hiroshi HaginoEmail author
  • Akinori Sakai
  • Satoshi Ikeda
  • Yasuo Imanishi
  • Hiroshi Tsurukami
  • Satoru Nakajo
  • Naohisa Miyakoshi
Original Article
  • 527 Downloads

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.

Keywords

Osteoporosis Monthly intravenous ibandronate Low responder Oral bisphosphonate MOVEMENT study 

Notes

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.

Author 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.

Compliance with ethical standards

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.

Supplementary material

774_2019_1005_MOESM1_ESM.docx (18 kb)
Supplementary material 1 (DOCX 18 kb)

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Copyright information

© Springer Japan KK, part of Springer Nature 2019

Authors and Affiliations

  • Hiroshi Hagino
    • 1
    Email author
  • Akinori Sakai
    • 2
  • Satoshi Ikeda
    • 3
  • Yasuo Imanishi
    • 4
  • Hiroshi Tsurukami
    • 5
  • Satoru Nakajo
    • 6
  • Naohisa Miyakoshi
    • 7
  1. 1.School of Health Science, Faculty of MedicineTottori UniversityYonagoJapan
  2. 2.Department of Orthopedic SurgeryUniversity of Occupational and Environmental HealthKitakyushuJapan
  3. 3.Department of Orthopedic SurgeryKen-Ai Memorial HospitalOngaJapan
  4. 4.Department of Metabolism, Endocrinology and Molecular MedicineOsaka City University Graduate School of MedicineOsakaJapan
  5. 5.Tsurukami Clinic of Orthopedics and RheumatologyTamanaJapan
  6. 6.Nakajou Orthopedic ClinicSendaiJapan
  7. 7.Department of Orthopedic SurgeryAkita University Graduate School of MedicineAkitaJapan

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