Abstract
We examined response to bone mineral density (BMD) gains in the MOVER study following treatment with intravenous (IV) ibandronate 1 mg/month, and investigated the characteristics of a non-responder group. At 1 year, responder rates for patients with BMD increases >0 % were similar with IV ibandronate 0.5 or 1 mg/month and oral risedronate 2.5 mg/day. However, after 3 years, responder rates with BMD increases ≥3 % were highest with ibandronate 1 mg at all bone sites (>80 % at the lumbar spine [L2–L4] and >50 % at all femur sites, which was significantly higher than with risedronate). Non-responders were defined by BMD increases ≤3 % at L2–L4 or ≤0 % at total hip, and ≤50 % reduction in creatinine-corrected urinary collagen type 1 cross-linked C-telopeptide (uCTX) from baseline to 1 year. There were a small number of non-responders in the ibandronate 1 mg group: 3.3 % (10/299) with ≤0 % total hip BMD increase and ≤50 % uCTX reduction from baseline. These non-responders had lower 25-hydroxyvitamin D (25[OH]D) levels than responders, but no differences in kidney function, L2–L4 BMD or bone turnover marker baseline values. Throughout the study, non-responders failed to show any increases in BMD. Our analysis demonstrates significantly higher responder rates with IV ibandronate 1 mg/month than with risedronate at 3 years. A small number of non-responders in the ibandronate group had lower 25(OH)D baseline levels than responders, suggesting that 25(OH)D levels could be a useful indicator of BMD response to therapy.
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Acknowledgments
All analyses for publication were the responsibility of Chugai Pharmaceutical Co. Ltd. All authors contributed to the manuscript and have approved the final version for submission. The authors acknowledge Dr. Daiva Masanauskaite and Dr. Joseph Kohles of F. Hoffmann-La Roche Ltd. for discussing the results with them. The MOVER study was funded by Chugai Pharmaceutical Co. Ltd. and Taisho Pharmaceutical Co. Ltd. Support for third-party writing assistance for this manuscript was provided by Chugai Pharmaceutical Co. Ltd.
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Tetsuo Nakano has received consulting fees from Asahi Kasei Pharma Corp., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Inc., and Teijin Pharma Ltd. Masao Yamamoto, Junko Hashimoto, Masato Tobinai, and Seitaro Yoshida are employees of Chugai Pharmaceutical Co. Ltd. Toshitara Nakamura has received research grants and/or consulting fees from Asahi Kasei Pharma Corp., Astellas Pharma Inc., Banyu Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Inc., Eisai Co. Ltd., Eli Lilly Japan K.K., Ono Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., and Teijin Pharma Ltd., and belongs to the Japan Ministry of Health, Welfare and Labor as a councillor for hospital administration and social medical insurance.
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Nakano, T., Yamamoto, M., Hashimoto, J. et al. 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 (2016). https://doi.org/10.1007/s00774-015-0717-8
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DOI: https://doi.org/10.1007/s00774-015-0717-8