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Article: Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled phase 3 study of postmenopausal women with osteoporosis

TitleSafety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled phase 3 study of postmenopausal women with osteoporosis
Authors
Issue Date2010
PublisherBioMed Central Ltd. The Journal's web site is located at http://www.biomedcentral.com/bmcmusculoskeletdisord/
Citation
Bmc Musculoskeletal Disorders, 2010, v. 11 How to Cite?
AbstractBackground. We report the safety findings from a 3-year phase 3 study (NCT00205777) of bazedoxifene, a novel selective estrogen receptor modulator under development for the prevention and treatment of postmenopausal osteoporosis. Methods. Healthy postmenopausal osteoporotic women (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. Safety and tolerability were assessed by adverse event (AE) reporting and routine physical, gynecologic, and breast examination. Results. Overall, the incidence of AEs, serious AEs, and discontinuations due to AEs in the bazedoxifene groups was not different from that seen in the placebo group. The incidence of hot flushes and leg cramps was higher with bazedoxifene or raloxifene compared with placebo. The rates of cardiac disorders and cerebrovascular events were low and evenly distributed among groups. Venous thromboembolic events, primarily deep vein thromboses, were more frequently reported in the active treatment groups compared with the placebo group; rates were similar with bazedoxifene and raloxifene. Bazedoxifene showed a neutral effect on the breast and an excellent endometrial safety profile. The incidence of fibrocystic breast disease was lower with bazedoxifene 20 and 40 mg versus raloxifene or placebo. Reductions in total and low-density lipoprotein levels and increases in high-density lipoprotein levels were seen with bazedoxifene versus placebo; similar results were seen with raloxifene. Triglyceride levels were similar among groups. Conclusion. Bazedoxifene showed a favorable safety and tolerability profile in women with postmenopausal osteoporosis. © 2010 Christiansen et al; licensee BioMed Central Ltd.
Persistent Identifierhttp://hdl.handle.net/10722/163324
ISSN
2015 Impact Factor: 1.684
2015 SCImago Journal Rankings: 0.881
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorChristiansen, Cen_US
dc.contributor.authorChesnut, CHen_US
dc.contributor.authorAdachi, JDen_US
dc.contributor.authorBrown, JPen_US
dc.contributor.authorFernandes, CEen_US
dc.contributor.authorKung, AWCen_US
dc.contributor.authorPalacios, Sen_US
dc.contributor.authorLevine, ABen_US
dc.contributor.authorChines, AAen_US
dc.contributor.authorConstantine, GDen_US
dc.date.accessioned2012-09-05T05:30:04Z-
dc.date.available2012-09-05T05:30:04Z-
dc.date.issued2010en_US
dc.identifier.citationBmc Musculoskeletal Disorders, 2010, v. 11en_US
dc.identifier.issn1471-2474en_US
dc.identifier.urihttp://hdl.handle.net/10722/163324-
dc.description.abstractBackground. We report the safety findings from a 3-year phase 3 study (NCT00205777) of bazedoxifene, a novel selective estrogen receptor modulator under development for the prevention and treatment of postmenopausal osteoporosis. Methods. Healthy postmenopausal osteoporotic women (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. Safety and tolerability were assessed by adverse event (AE) reporting and routine physical, gynecologic, and breast examination. Results. Overall, the incidence of AEs, serious AEs, and discontinuations due to AEs in the bazedoxifene groups was not different from that seen in the placebo group. The incidence of hot flushes and leg cramps was higher with bazedoxifene or raloxifene compared with placebo. The rates of cardiac disorders and cerebrovascular events were low and evenly distributed among groups. Venous thromboembolic events, primarily deep vein thromboses, were more frequently reported in the active treatment groups compared with the placebo group; rates were similar with bazedoxifene and raloxifene. Bazedoxifene showed a neutral effect on the breast and an excellent endometrial safety profile. The incidence of fibrocystic breast disease was lower with bazedoxifene 20 and 40 mg versus raloxifene or placebo. Reductions in total and low-density lipoprotein levels and increases in high-density lipoprotein levels were seen with bazedoxifene versus placebo; similar results were seen with raloxifene. Triglyceride levels were similar among groups. Conclusion. Bazedoxifene showed a favorable safety and tolerability profile in women with postmenopausal osteoporosis. © 2010 Christiansen et al; licensee BioMed Central Ltd.en_US
dc.languageengen_US
dc.publisherBioMed Central Ltd. The Journal's web site is located at http://www.biomedcentral.com/bmcmusculoskeletdisord/en_US
dc.relation.ispartofBMC Musculoskeletal Disordersen_US
dc.titleSafety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled phase 3 study of postmenopausal women with osteoporosisen_US
dc.typeArticleen_US
dc.identifier.emailKung, AWC:awckung@hku.hken_US
dc.identifier.authorityKung, AWC=rp00368en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1186/1471-2474-11-130en_US
dc.identifier.pmid20569451-
dc.identifier.scopuseid_2-s2.0-77954885674en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-77954885674&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume11en_US
dc.identifier.isiWOS:000280832600001-
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridChristiansen, C=36040368300en_US
dc.identifier.scopusauthoridChesnut, CH=7005992585en_US
dc.identifier.scopusauthoridAdachi, JD=26643401000en_US
dc.identifier.scopusauthoridBrown, JP=26425595700en_US
dc.identifier.scopusauthoridFernandes, CE=7103089968en_US
dc.identifier.scopusauthoridKung, AWC=7102322339en_US
dc.identifier.scopusauthoridPalacios, S=7006012524en_US
dc.identifier.scopusauthoridLevine, AB=24076620500en_US
dc.identifier.scopusauthoridChines, AA=7003344761en_US
dc.identifier.scopusauthoridConstantine, GD=7006841339en_US

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