{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T06:46:05Z","timestamp":1790664365308,"version":"4.1.0"},"reference-count":21,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2014,2,9]],"date-time":"2014-02-09T00:00:00Z","timestamp":1391904000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2014,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>Bazedoxifene is a novel selective estrogen receptor modulator in clinical development for the prevention and treatment of postmenopausal osteoporosis. This phase 1, double\u2010blind, randomized, placebo\u2010controlled study (N\u2009=\u2009107) of healthy postmenopausal women examined the pharmacokinetics and safety\/tolerability profile of multiple doses of bazedoxifene (1, 2.5, 5, 10, 20, 40, and 80\u2009mg) administered orally once daily for 30 days. Bazedoxifene demonstrated a half\u2010life of 25 to 30\u2009hours, reached steady state within 7 days, and exhibited linear pharmacokinetics over a dose range of 5\u201380\u2009mg. Fibrinogen levels decreased with bazedoxifene doses of 5\u2009mg and greater; these changes were significant for bazedoxifene 20, 40, and 80\u2009mg (<jats:italic>P<\/jats:italic>\u2009\u2264\u2009.05 vs placebo), but were not dose dependent. Bazedoxifene was associated with increased levels of sex hormone\u2010binding globulin, thyroxine\u2010binding globulin, and cortisol\u2010binding globulin (CBG); only increases in the levels of CBG appeared to be dose related. Bazedoxifene was safe and well tolerated within the tested dose range. Bazedoxifene showed no differences from placebo in adverse event reports, vital sign measurements, or electrocardiogram findings.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cpdd.102","type":"journal-article","created":{"date-parts":[[2014,1,4]],"date-time":"2014-01-04T05:49:53Z","timestamp":1388814593000},"page":"262-269","source":"Crossref","is-referenced-by-count":11,"title":["A double\u2010blind, randomized, ascending, multiple\u2010dose study of bazedoxifene in healthy postmenopausal women"],"prefix":"10.1002","volume":"3","author":[{"given":"William E.","family":"McKeand","sequence":"first","affiliation":[{"name":"Pfizer Inc Collegeville PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gayle P.","family":"Orczyk","sequence":"additional","affiliation":[{"name":"No longer affiliated with Pfizer Inc USA"},{"name":"Teva Pharmaceuticals North Wales PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James C.","family":"Ermer","sequence":"additional","affiliation":[{"name":"No longer affiliated with Pfizer Inc USA"},{"name":"Shire Pharmaceuticals Wayne PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arkadi A.","family":"Chines","sequence":"additional","affiliation":[{"name":"No longer affiliated with Pfizer Inc USA"},{"name":"Amgen Inc Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,2,9]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/gme.0b013e3181c617e6"},{"issue":"11","key":"e_1_2_7_3_1","first-page":"910","article-title":"Guidelines for the management of postmenopausal osteoporosis for GPs","volume":"33","author":"O'Neill S","year":"2004","journal-title":"Aust Fam Physician."},{"issue":"7","key":"e_1_2_7_4_1","first-page":"1293","article-title":"Pharmacologic prevention of osteoporotic fractures","volume":"70","author":"Zizic TM","year":"2004","journal-title":"Am Fam Physician."},{"key":"e_1_2_7_5_1","unstructured":"Wyeth's Conbriza (bazedoxifene) approved in Europe for postmenopausal osteoporosis.http:\/\/www.news\u2010medical.net\/news\/2009\/04\/27\/48933.aspx. 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