caa a22 4500 605462887 CHVBK 20210128100250.0 cr unu---uuuuu 210128e20150101xx s 000 0 eng 10.1007/s00774-013-0554-6 doi (NATIONALLICENCE)springer-10.1007/s00774-013-0554-6 Bridging analysis of the efficacy and safety of bazedoxifene in Japanese and global populations of postmenopausal women with osteoporosis [Elektronische Daten] [Akira Itabashi, Kousei Yoh, Arkadi Chines, Takami Miki, Masahiko Takada, Hiroshi Sato, Itsuo Gorai, Toshitsugu Sugimoto, Hideki Mizunuma, Hiroshi Ochi, Ginger Constantine, Hiroaki Ohta] This study examined whether the global clinical data for bazedoxifene could be extrapolated to a Japanese population by evaluating the results of a phase 2 study in postmenopausal Japanese women with osteoporosis as compared to those of a pivotal, phase 3 study. The efficacy of bazedoxifene 20 and 40mg versus placebo on lumbar spine bone mineral density (BMD), bone turnover markers, lipid profile, incidence of fractures, and safety parameters was compared between the Japanese phase 2 study (N=429) and the global phase 3 study (N=7,492) during a 2-year period. In the primary population for assessment of bridging, differences in the mean percent change from baseline in lumbar spine BMD at 2years relative to placebo were greater for women treated with bazedoxifene 20 and 40mg in the phase 2 study than in the phase 3 study. BMD changes in the bazedoxifene groups were confirmed to be similar between the phase 2 study population and a subset of the phase 3 study population with similar baseline characteristics. The effects of bazedoxifene on incidence of fractures, bone turnover markers, and lipid metabolism were similar between studies. There were no major differences in safety parameters between studies. The greater improvement in lumbar spine BMD and similar results in bone turnover markers, fracture incidence, and safety profile observed with bazedoxifene in the phase 2 study compared with the phase 3 study confirmed the feasibility of extrapolating the global clinical data to a Japanese population. The Japanese Society for Bone and Mineral Research and Springer Japan, 2014 Bazedoxifene nationallicence Postmenopausal osteoporosis nationallicence Treatment nationallicence Selective estrogen receptor modulator nationallicence Bone mineral density nationallicence Itabashi Akira Saitama Center for Bone Research, Kubojima Clinic, 1785-2 Kubojima, 360-0831, Kumagaya, Saitama, Japan aut Yoh Kousei Hyogo College of Medicine, Sasayama Medical Center, Sasayama, Hyogo, Japan aut Chines Arkadi Pfizer Inc, Collegeville, PA, USA aut Miki Takami Osaka City University Medical School, Osaka, Osaka, Japan aut Takada Masahiko Shiga University of Medical Science, Otsu, Shiga, Japan aut Sato Hiroshi Niigata University of Health and Welfare, Niigata, Niigata, Japan aut Gorai Itsuo International University of Health and Welfare, Atami Hospital, Atami, Shizuoka, Japan aut Sugimoto Toshitsugu Shimane University Faculty of Medicine, Izumo, Shimane, Japan aut Mizunuma Hideki Hirosaki University School of Medicine, Hirosaki, Aomori, Japan aut Ochi Hiroshi Pfizer Inc, Tokyo, Japan aut Constantine Ginger Pfizer Inc, Collegeville, PA, USA aut Ohta Hiroaki International University of Health and Welfare, Sanno Medical Center, Tokyo, Japan aut Journal of Bone and Mineral Metabolism Springer Japan 33/1(2015-01-01), 61-72 0914-8779 33:1<61 2015 33 774 https://doi.org/10.1007/s00774-013-0554-6 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s00774-013-0554-6 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Itabashi Akira Saitama Center for Bone Research, Kubojima Clinic, 1785-2 Kubojima, 360-0831, Kumagaya, Saitama, Japan aut NATIONALLICENCE 700 1- Yoh Kousei Hyogo College of Medicine, Sasayama Medical Center, Sasayama, Hyogo, Japan aut NATIONALLICENCE 700 1- Chines Arkadi Pfizer Inc, Collegeville, PA, USA aut NATIONALLICENCE 700 1- Miki Takami Osaka City University Medical School, Osaka, Osaka, Japan aut NATIONALLICENCE 700 1- Takada Masahiko Shiga University of Medical Science, Otsu, Shiga, Japan aut NATIONALLICENCE 700 1- Sato Hiroshi Niigata University of Health and Welfare, Niigata, Niigata, Japan aut NATIONALLICENCE 700 1- Gorai Itsuo International University of Health and Welfare, Atami Hospital, Atami, Shizuoka, Japan aut NATIONALLICENCE 700 1- Sugimoto Toshitsugu Shimane University Faculty of Medicine, Izumo, Shimane, Japan aut NATIONALLICENCE 700 1- Mizunuma Hideki Hirosaki University School of Medicine, Hirosaki, Aomori, Japan aut NATIONALLICENCE 700 1- Ochi Hiroshi Pfizer Inc, Tokyo, Japan aut NATIONALLICENCE 700 1- Constantine Ginger Pfizer Inc, Collegeville, PA, USA aut NATIONALLICENCE 700 1- Ohta Hiroaki International University of Health and Welfare, Sanno Medical Center, Tokyo, Japan aut NATIONALLICENCE 773 0- Journal of Bone and Mineral Metabolism Springer Japan 33/1(2015-01-01), 61-72 0914-8779 33:1<61 2015 33 774