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Expert Opinion on Drug Safety Volume 18, 2019 - Issue 10
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Original Research

Safety of bazedoxifene in Korean women with post-menopausal osteoporosis: a post-marketing surveillance study (PMSS)

Ji Wan KimDepartment of Orthopaedic Surgery, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South KoreaView further author information
,
Ji Young LeeDepartment of Obstetrics and Gynecology, Konkuk University School of Medicine, Seoul, South KoreaView further author information
,
Hyung-Eun ParkMedical Affairs, Essential Health, Pfizer Pharmaceuticals Korea Ltd., Seoul, South KoreaView further author information
,
Sang-Hee KimMedical Affairs, Essential Health, Pfizer Pharmaceuticals Korea Ltd., Seoul, South KoreaView further author information
&
Yoon-Sok ChungDepartment of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, South KoreaCorrespondence[email protected]
View further author information
Pages 1001-1008 | Received 25 Feb 2019, Accepted 07 Aug 2019, Published online: 14 Aug 2019

References

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  • Silverman SL, Christiansen C, Genant HK, et al. Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial. J Bone Miner Res. 2008 Dec;23(12):1923–1934.
  • Ministry of Food and Drug Safety, Korea. Bezadoxifene Information. [cited 2019 Feb 24]. Available from: http://drug.mfds.go.kr/html/bxsSearchDrugProduct.jsp?item_Seq=201110095
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  • Itabashi A, Yoh K, Chines AA, et al. Effects of bazedoxifene on bone mineral density, bone turnover, and safety in postmenopausal Japanese women with osteoporosis. J Bone Miner Res. 2011 Mar;26(3):519–529.
  • de Villiers TJ, Chines AA, Palacios S, et al. Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial. Osteoporos Int. 2011 Feb;22(2):567–576.
  • Ki-Chan A. Selective estrogen receptor modulators. Asian Spine J. 2016 Aug;10(4):787–791.
  • Takeuchi Y, Hamaya E, Taketsuna M, et al. Safety of 3-year raloxifene treatment in Japanese postmenopausal women aged 75 years or older with osteoporosis: a postmarketing surveillance study. Menopause. 2015 Oct;22(10):1134–1137.

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