Effect of monthly intravenous ibandronate injectio

Authors: Masako Ito Masato Tobinai Seitaro Yoshida Junko Hashimoto Toshitaka Nakamura

Publish Date: 2015/11/27

Volume: 35, Issue: 1, Pages: 58-64

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Abstract

We examined the efficacy of intravenous IV ibandronate 1 mg/month in patient subgroups in the phase III MOVER study Here we present results of analyses on the incidence of fractures in patients with prevalent vertebral fractures 1 or ≥2 and ≥3 at screening and femoral neck FN bone mineral density BMD T scores ≥−25 or −25 and −30 at baseline The perprotocol set comprised 1134 patients ibandronate 05 mg/month n = 376 ibandronate 1 mg/month n = 382 risedronate oral 25 mg/day n = 376 The incidence of vertebral fractures in patients with 1 or ≥2 prevalent vertebral fractures was 112 and 204  respectively with ibandronate 1 mg/month and 126 and 221  respectively with risedronate In patients with FN BMD T scores ≥−25 or −25 the vertebral fracture incidence was 137 and 164  respectively with ibandronate 1 mg/month and 173 and 191  respectively with risedronate The incidence of nonvertebral fractures in patients with ≥2 prevalent vertebral fractures or FN BMD T score −25 was 76 and 76  respectively with ibandronate 1 mg/month and 95 and 94  respectively with risedronate Fracture incidence was consistently lower but not significant with ibandronate 1 mg/month than with risedronate in patients with ≥2 prevalent vertebral fractures and FN BMD T score −25 The efficacy of the fracture reduction of monthly IV ibandronate appears consistent and seemingly independent of the number of prevalent vertebral fractures or baseline BMD valuesAll 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 HoffmannLa 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 thirdparty writing assistance for this manuscript was provided by Chugai Pharmaceutical Co LtdMasako Ito has received consulting fees Asahi Kasei Pharma Corp Astellas Pharma Inc Chugai Pharmaceutical Co Ltd Daiichi Sankyo Inc and Ono Pharmaceutical Co Ltd Masato Tobinai Seitaro Yoshida and Junko Hashimoto are employees of Chugai Pharmaceutical Co Ltd Toshitaka Nakamura has received research grants and/or consulting fees Asahi Kasei Pharma Corp Astellas Pharma Inc Banyu Pharmaceutical Co Ltd Chugai Pharmaceutical Co Ltd Daiichi Sankyo Inc Eisai Co Ltd Eli Lilly Japan KK Ono Pharmaceutical Co Ltd Takeda Pharmaceutical Co Ltd and Teijin Pharma LtdAll procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards

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