3% (−52.5 to −22.1) in men vs −54.1%

(−55.3 to −52.9) in women; serum BGP were −43.8% (−50.7 to −36.9) in men vs −53.4% (−54.5 to 52.4) in women; urinary NTX were −49.3% (−65.0 to −33.5) in men vs −64.5% (−66.4 to −62.5) in women; and urinary DPD were Obeticholic Acid mw −19.8% (−37.3 to −2.8) in men vs −26.9% (−28.7 to −25.0). Further studies would be needed to evaluate whether there would be sex difference in the responses to minodronate. The present study demonstrated that oral minodronate administered monthly has comparable efficacy and safety to the daily regimen, which has been shown to have anti-VFx efficacy. This new monthly regimen will give patients with osteoporosis a new dosage option for minodronate, which may lead to better medication compliance for this bisphosphonate. Acknowledgments We thank Astellas Pharma Inc.

for their scientific and technical support, Ono Pharmaceutical Co., Ltd. for providing supportive data and the following investigators and clinical sites in Japan which participated in this study: M. Harada, Naganuma Orthopedics & Rehabilitation Medical Institution; M. Jinnouchi, Nishi Waseda Orthopaedic Surgery; T. Nakamura, Medical Foundation Syukokai Abe Clinic; K. Akazawa, Akazawa Clinic; H. Hanashi, BGB324 clinical trial Medical Corporation Seikokai, New Medical Research System Clinic; D. Kubodera, Medical Corporation Eisinkai Kubodera Orthopaedic; H. Yamane, Toyooka-daiichi Hospital; M. Iwahashi, Medical Corporation Toyooka Orthopaedic Hospital; H. Kim, Yokohama Minoru Clinic, Shintoukai Medical Corporation; Y. Ohtake, The Kanazawa Hospital, Keisuikai Medical Corporation; T. Okawa, Okawa Orthopaedic Surgery Clinic; T. Sakata, Social Medical Corporation Reimei-kai Kitade Hospital; Y. Sakai, Medical Corporation Heiseikai Sunrise Sakai Hospital; R. Kikuno, Kikuno Hospital Medical Corporation Kikuno Association; J. Shiomi,

Shiomi Orthopaedics; M. Kajitani, Koseinenkin Kochi Rehabilitation Hospital; S. Kawashita, Tonan Hospital; A. Myojin, Kohoku Hospital; T. Maeda, Maeda Hospital; M. Otani, Koryo Hospital; M. Morita, Acyl CoA dehydrogenase Susaki Kuroshio Hospital; M. Noguchi, Shinagawa East One Medical Clinic; M. Omata, Tiida Ohimachi Orthopedic Surgery Clinic; M. Nakayama, Tiida Yokohama Motomachi Clinic; K. Suzuki, Kenkokan Suzuki Clinic; H. Shimomura, Musashino Clinic; S. Wada, Wada Orthopedic Clinic; F. Omura, Koenji Orthopedic Surgery; K. Sakamoto, Nishikamata SeikeiGeka; Y. Nemoto, Iryohojin NemotoGeka; and T. Yokoyama, Kitashinagawa Third Hospital Funding This study was sponsored by Astellas Pharma Inc., and Ono Pharmaceutical Co., Ltd. The authors were supported in the editing and writing of this manuscript, and sponsored by Astellas Pharma Inc., and Ono Pharmaceutical Co., Ltd. The authors are fully responsible for the content and editorial decisions for this manuscript. Conflicts of interest Dr. R.