Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial
Summary Findings from this 5-year phase 3 study of postmenopausal women with osteoporosis showed that bazedoxifene was associated with an overall favorable safety and tolerability profile, with no evidence of endometrial or breast stimulation. Overall, the results at 5 years were consistent with tho...
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| Veröffentlicht in: | Osteoporosis international 2011-02, Vol.22 (2), p.567-576 |
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| creator | de Villiers, T. J Chines, A. A Palacios, S Lips, P Sawicki, A. Z Levine, A. B Codreanu, C Kelepouris, N Brown, J. P |
| description | Summary Findings from this 5-year phase 3 study of postmenopausal women with osteoporosis showed that bazedoxifene was associated with an overall favorable safety and tolerability profile, with no evidence of endometrial or breast stimulation. Overall, the results at 5 years were consistent with those seen at 3 years. Introduction We report safety and tolerability findings from a 5-year randomized, double-blind, phase 3 study of bazedoxifene in postmenopausal women with osteoporosis. Methods In the core study, healthy postmenopausal women with osteoporosis (N = 7,492; mean age, 66.4 years) were randomized to daily doses of bazedoxifene 20 or 40 mg, raloxifene 60 mg, or placebo for 3 years. During the 2-year study extension, the raloxifene 60-mg treatment arm was discontinued after the 3-year database was finalized, and subjects receiving bazedoxifene 40 mg were transitioned in a blinded manner to bazedoxifene 20 mg (bazedoxifene 40-/20-mg group) after 4 years. Safety and tolerability data are reported for subjects in the bazedoxifene 20- and 40-/20-mg and placebo groups; efficacy findings are reported elsewhere. Results A total of 3,146 subjects in the bazedoxifene 20- and 40-mg and placebo groups were enrolled in the extension study (years 4 and 5). Overall, the 5-year incidence of adverse events (AEs), serious AEs, and discontinuations due to AEs were similar among groups. The incidence of hot flushes and leg cramps was higher with bazedoxifene compared with placebo. Venous thromboembolic events, primarily deep vein thrombosis, were more frequently reported in the bazedoxifene groups compared with the placebo group. Reports of cardiac disorders and cerebrovascular events were few and evenly distributed among groups. Bazedoxifene showed a neutral effect on the breast and endometrium. Conclusion Bazedoxifene was associated with an overall favorable safety and tolerability profile in postmenopausal women with osteoporosis over 5 years of therapy, consistent with findings at 3 years. |
| doi_str_mv | 10.1007/s00198-010-1302-6 |
| format | Article |
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J ; Chines, A. A ; Palacios, S ; Lips, P ; Sawicki, A. Z ; Levine, A. B ; Codreanu, C ; Kelepouris, N ; Brown, J. P</creator><creatorcontrib>de Villiers, T. J ; Chines, A. A ; Palacios, S ; Lips, P ; Sawicki, A. Z ; Levine, A. B ; Codreanu, C ; Kelepouris, N ; Brown, J. P</creatorcontrib><description>Summary Findings from this 5-year phase 3 study of postmenopausal women with osteoporosis showed that bazedoxifene was associated with an overall favorable safety and tolerability profile, with no evidence of endometrial or breast stimulation. Overall, the results at 5 years were consistent with those seen at 3 years. Introduction We report safety and tolerability findings from a 5-year randomized, double-blind, phase 3 study of bazedoxifene in postmenopausal women with osteoporosis. Methods In the core study, healthy postmenopausal women with osteoporosis (N = 7,492; mean age, 66.4 years) were randomized to daily doses of bazedoxifene 20 or 40 mg, raloxifene 60 mg, or placebo for 3 years. During the 2-year study extension, the raloxifene 60-mg treatment arm was discontinued after the 3-year database was finalized, and subjects receiving bazedoxifene 40 mg were transitioned in a blinded manner to bazedoxifene 20 mg (bazedoxifene 40-/20-mg group) after 4 years. Safety and tolerability data are reported for subjects in the bazedoxifene 20- and 40-/20-mg and placebo groups; efficacy findings are reported elsewhere. Results A total of 3,146 subjects in the bazedoxifene 20- and 40-mg and placebo groups were enrolled in the extension study (years 4 and 5). Overall, the 5-year incidence of adverse events (AEs), serious AEs, and discontinuations due to AEs were similar among groups. The incidence of hot flushes and leg cramps was higher with bazedoxifene compared with placebo. Venous thromboembolic events, primarily deep vein thrombosis, were more frequently reported in the bazedoxifene groups compared with the placebo group. Reports of cardiac disorders and cerebrovascular events were few and evenly distributed among groups. Bazedoxifene showed a neutral effect on the breast and endometrium. Conclusion Bazedoxifene was associated with an overall favorable safety and tolerability profile in postmenopausal women with osteoporosis over 5 years of therapy, consistent with findings at 3 years.</description><identifier>ISSN: 0937-941X</identifier><identifier>EISSN: 1433-2965</identifier><identifier>DOI: 10.1007/s00198-010-1302-6</identifier><identifier>PMID: 20535606</identifier><language>eng</language><publisher>London: London : Springer-Verlag</publisher><subject>Aged ; Aged, 80 and over ; Bazedoxifene ; Biological and medical sciences ; Clinical trials ; Diseases of the osteoarticular system ; Double-Blind Method ; Drug therapy ; Endocrinology ; Female ; Hot Flashes - chemically induced ; Humans ; Indoles - adverse effects ; Indoles - therapeutic use ; Medical sciences ; Medicine ; Medicine & Public Health ; Menopause ; Middle Aged ; Muscle Cramp - chemically induced ; Original Article ; Orthopedics ; Osteoporosis ; Osteoporosis, Postmenopausal - drug therapy ; Osteoporosis. Osteomalacia. Paget disease ; Patient safety ; Postmenopausal ; Rheumatology ; Safety ; Selective Estrogen Receptor Modulators - adverse effects ; Selective Estrogen Receptor Modulators - therapeutic use ; SERMs ; Tolerability ; Treatment Outcome ; Venous Thrombosis - chemically induced ; Women</subject><ispartof>Osteoporosis international, 2011-02, Vol.22 (2), p.567-576</ispartof><rights>International Osteoporosis Foundation and National Osteoporosis Foundation 2010</rights><rights>2015 INIST-CNRS</rights><rights>International Osteoporosis Foundation and National Osteoporosis Foundation 2011</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c481t-579f1ad504977ab799a35dc4f94f6da95bd6b29be1bb7d5bbc6e5a6aca58aef63</citedby><cites>FETCH-LOGICAL-c481t-579f1ad504977ab799a35dc4f94f6da95bd6b29be1bb7d5bbc6e5a6aca58aef63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00198-010-1302-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00198-010-1302-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23829487$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20535606$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>de Villiers, T. J</creatorcontrib><creatorcontrib>Chines, A. A</creatorcontrib><creatorcontrib>Palacios, S</creatorcontrib><creatorcontrib>Lips, P</creatorcontrib><creatorcontrib>Sawicki, A. Z</creatorcontrib><creatorcontrib>Levine, A. B</creatorcontrib><creatorcontrib>Codreanu, C</creatorcontrib><creatorcontrib>Kelepouris, N</creatorcontrib><creatorcontrib>Brown, J. P</creatorcontrib><title>Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial</title><title>Osteoporosis international</title><addtitle>Osteoporos Int</addtitle><addtitle>Osteoporos Int</addtitle><description>Summary Findings from this 5-year phase 3 study of postmenopausal women with osteoporosis showed that bazedoxifene was associated with an overall favorable safety and tolerability profile, with no evidence of endometrial or breast stimulation. Overall, the results at 5 years were consistent with those seen at 3 years. Introduction We report safety and tolerability findings from a 5-year randomized, double-blind, phase 3 study of bazedoxifene in postmenopausal women with osteoporosis. Methods In the core study, healthy postmenopausal women with osteoporosis (N = 7,492; mean age, 66.4 years) were randomized to daily doses of bazedoxifene 20 or 40 mg, raloxifene 60 mg, or placebo for 3 years. During the 2-year study extension, the raloxifene 60-mg treatment arm was discontinued after the 3-year database was finalized, and subjects receiving bazedoxifene 40 mg were transitioned in a blinded manner to bazedoxifene 20 mg (bazedoxifene 40-/20-mg group) after 4 years. Safety and tolerability data are reported for subjects in the bazedoxifene 20- and 40-/20-mg and placebo groups; efficacy findings are reported elsewhere. Results A total of 3,146 subjects in the bazedoxifene 20- and 40-mg and placebo groups were enrolled in the extension study (years 4 and 5). Overall, the 5-year incidence of adverse events (AEs), serious AEs, and discontinuations due to AEs were similar among groups. The incidence of hot flushes and leg cramps was higher with bazedoxifene compared with placebo. Venous thromboembolic events, primarily deep vein thrombosis, were more frequently reported in the bazedoxifene groups compared with the placebo group. Reports of cardiac disorders and cerebrovascular events were few and evenly distributed among groups. Bazedoxifene showed a neutral effect on the breast and endometrium. Conclusion Bazedoxifene was associated with an overall favorable safety and tolerability profile in postmenopausal women with osteoporosis over 5 years of therapy, consistent with findings at 3 years.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Bazedoxifene</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Diseases of the osteoarticular system</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Endocrinology</subject><subject>Female</subject><subject>Hot Flashes - chemically induced</subject><subject>Humans</subject><subject>Indoles - adverse effects</subject><subject>Indoles - therapeutic use</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Menopause</subject><subject>Middle Aged</subject><subject>Muscle Cramp - chemically induced</subject><subject>Original Article</subject><subject>Orthopedics</subject><subject>Osteoporosis</subject><subject>Osteoporosis, Postmenopausal - drug therapy</subject><subject>Osteoporosis. Osteomalacia. Paget disease</subject><subject>Patient safety</subject><subject>Postmenopausal</subject><subject>Rheumatology</subject><subject>Safety</subject><subject>Selective Estrogen Receptor Modulators - adverse effects</subject><subject>Selective Estrogen Receptor Modulators - therapeutic use</subject><subject>SERMs</subject><subject>Tolerability</subject><subject>Treatment Outcome</subject><subject>Venous Thrombosis - chemically induced</subject><subject>Women</subject><issn>0937-941X</issn><issn>1433-2965</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kc1u1TAQhSMEopfCA7ABCwl104Adx3HMDlUUkCqxKJXYRWNn3Lpy4mAnKpfn4IFxlAuVWLCyxvPNmZ9TFM8ZfcMolW8TpUy1JWW0ZJxWZfOg2LGa87JSjXhY7KjislQ1-3ZUPEnpluYapeTj4qiigouGNrvi1yVYnPcExp7MwWME7bzLH8ESDT-xDz-cxRGJG8kU0jzgGCZYEnhyF3JA7tx8Q3ICwxRiSC69IxHT4ue0SgAR5R4hnpKYO4TBZcVTMnkwqENpwjjH4D32ZLqBhISTOTrwT4tHFnzCZ4f3uLg6__D17FN58eXj57P3F6WpWzaXQirLoBe0VlKCzrsBF72prapt04MSum90pTQyrWUvtDYNCmjAgGgBbcOPi5NNd4rh-4Jp7gaXDHoPI4YldUrUDVVCreSrf8jbsMQxD9e1XNZSCcEyxDbI5EOkiLabohsg7jtGu9WwbjOso2ucDetW4RcH4UUP2P-t-ONQBl4fAEgGvM13NC7dc7ytVN3KzFUbl3JqvMZ4P-H_ur_ciiyEDq5jFr66rGjOMlVJWnH-G8luuhc</recordid><startdate>20110201</startdate><enddate>20110201</enddate><creator>de Villiers, T. 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P</creator><general>London : Springer-Verlag</general><general>Springer-Verlag</general><general>Springer</general><general>Springer Nature B.V</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QP</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20110201</creationdate><title>Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial</title><author>de Villiers, T. J ; Chines, A. A ; Palacios, S ; Lips, P ; Sawicki, A. Z ; Levine, A. B ; Codreanu, C ; Kelepouris, N ; Brown, J. P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c481t-579f1ad504977ab799a35dc4f94f6da95bd6b29be1bb7d5bbc6e5a6aca58aef63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Bazedoxifene</topic><topic>Biological and medical sciences</topic><topic>Clinical trials</topic><topic>Diseases of the osteoarticular system</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Endocrinology</topic><topic>Female</topic><topic>Hot Flashes - chemically induced</topic><topic>Humans</topic><topic>Indoles - adverse effects</topic><topic>Indoles - therapeutic use</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Menopause</topic><topic>Middle Aged</topic><topic>Muscle Cramp - chemically induced</topic><topic>Original Article</topic><topic>Orthopedics</topic><topic>Osteoporosis</topic><topic>Osteoporosis, Postmenopausal - drug therapy</topic><topic>Osteoporosis. Osteomalacia. Paget disease</topic><topic>Patient safety</topic><topic>Postmenopausal</topic><topic>Rheumatology</topic><topic>Safety</topic><topic>Selective Estrogen Receptor Modulators - adverse effects</topic><topic>Selective Estrogen Receptor Modulators - therapeutic use</topic><topic>SERMs</topic><topic>Tolerability</topic><topic>Treatment Outcome</topic><topic>Venous Thrombosis - chemically induced</topic><topic>Women</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>de Villiers, T. J</creatorcontrib><creatorcontrib>Chines, A. A</creatorcontrib><creatorcontrib>Palacios, S</creatorcontrib><creatorcontrib>Lips, P</creatorcontrib><creatorcontrib>Sawicki, A. Z</creatorcontrib><creatorcontrib>Levine, A. B</creatorcontrib><creatorcontrib>Codreanu, C</creatorcontrib><creatorcontrib>Kelepouris, N</creatorcontrib><creatorcontrib>Brown, J. P</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Osteoporosis international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>de Villiers, T. J</au><au>Chines, A. A</au><au>Palacios, S</au><au>Lips, P</au><au>Sawicki, A. Z</au><au>Levine, A. B</au><au>Codreanu, C</au><au>Kelepouris, N</au><au>Brown, J. P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial</atitle><jtitle>Osteoporosis international</jtitle><stitle>Osteoporos Int</stitle><addtitle>Osteoporos Int</addtitle><date>2011-02-01</date><risdate>2011</risdate><volume>22</volume><issue>2</issue><spage>567</spage><epage>576</epage><pages>567-576</pages><issn>0937-941X</issn><eissn>1433-2965</eissn><abstract>Summary Findings from this 5-year phase 3 study of postmenopausal women with osteoporosis showed that bazedoxifene was associated with an overall favorable safety and tolerability profile, with no evidence of endometrial or breast stimulation. Overall, the results at 5 years were consistent with those seen at 3 years. Introduction We report safety and tolerability findings from a 5-year randomized, double-blind, phase 3 study of bazedoxifene in postmenopausal women with osteoporosis. Methods In the core study, healthy postmenopausal women with osteoporosis (N = 7,492; mean age, 66.4 years) were randomized to daily doses of bazedoxifene 20 or 40 mg, raloxifene 60 mg, or placebo for 3 years. During the 2-year study extension, the raloxifene 60-mg treatment arm was discontinued after the 3-year database was finalized, and subjects receiving bazedoxifene 40 mg were transitioned in a blinded manner to bazedoxifene 20 mg (bazedoxifene 40-/20-mg group) after 4 years. Safety and tolerability data are reported for subjects in the bazedoxifene 20- and 40-/20-mg and placebo groups; efficacy findings are reported elsewhere. Results A total of 3,146 subjects in the bazedoxifene 20- and 40-mg and placebo groups were enrolled in the extension study (years 4 and 5). Overall, the 5-year incidence of adverse events (AEs), serious AEs, and discontinuations due to AEs were similar among groups. The incidence of hot flushes and leg cramps was higher with bazedoxifene compared with placebo. Venous thromboembolic events, primarily deep vein thrombosis, were more frequently reported in the bazedoxifene groups compared with the placebo group. Reports of cardiac disorders and cerebrovascular events were few and evenly distributed among groups. Bazedoxifene showed a neutral effect on the breast and endometrium. Conclusion Bazedoxifene was associated with an overall favorable safety and tolerability profile in postmenopausal women with osteoporosis over 5 years of therapy, consistent with findings at 3 years.</abstract><cop>London</cop><pub>London : Springer-Verlag</pub><pmid>20535606</pmid><doi>10.1007/s00198-010-1302-6</doi><tpages>10</tpages></addata></record> |
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| subjects | Aged Aged, 80 and over Bazedoxifene Biological and medical sciences Clinical trials Diseases of the osteoarticular system Double-Blind Method Drug therapy Endocrinology Female Hot Flashes - chemically induced Humans Indoles - adverse effects Indoles - therapeutic use Medical sciences Medicine Medicine & Public Health Menopause Middle Aged Muscle Cramp - chemically induced Original Article Orthopedics Osteoporosis Osteoporosis, Postmenopausal - drug therapy Osteoporosis. Osteomalacia. Paget disease Patient safety Postmenopausal Rheumatology Safety Selective Estrogen Receptor Modulators - adverse effects Selective Estrogen Receptor Modulators - therapeutic use SERMs Tolerability Treatment Outcome Venous Thrombosis - chemically induced Women |
| title | Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial |
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