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Article: Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: Results of a 5-year, randomized, placebo-controlled study

TitleSustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: Results of a 5-year, randomized, placebo-controlled study
Authors
Issue Date2012
PublisherSpringer U K. The Journal's web site is located at http://www.springer.com/medicine/orthopedics/journal/198
Citation
Osteoporosis International, 2012, v. 23 n. 1, p. 351-363 How to Cite?
AbstractSummary In this 2-year extension of a 3-year study, bazedoxifene showed sustained efficacy in preventing new vertebral fractures in postmenopausal women with osteoporosis and in preventing non-vertebral fractures in higherrisk women. Bazedoxifene significantly increased bone mineral density and reduced bone turnover versus placebo and was generally safe and well tolerated. Introduction This study evaluated the efficacy and safety of bazedoxifene for the treatment of postmenopausal osteoporosis over 5 years. Methods A total of 4,216 postmenopausal women with osteoporosis were enrolled in this 2-year extension of a 3-year, randomized, double-blind, placebo-controlled, phase 3 trial. In the core study (N=7,492), subjects received bazedoxifene 20 or 40 mg/day, raloxifene 60 mg/day, or placebo. The raloxifene arm was discontinued after 3 years; subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after 4 years. Five-year findings are reported for bazedoxifene 20 and 40/20 mg and placebo. Endpoints included incidence of new vertebral fractures (primary) and non-vertebral fractures, and changes in bone mineral density (BMD) and bone turnover markers. Results At 5 years, the incidence of new vertebral fractures in the intent-to-treat population was significantly lower with bazedoxifene 20 mg (4.5%) and 40/20 mg (3.9%) versus placebo (6.8%; P<0.05), with relative risk reductions of 35% and 40%, respectively. Non-vertebral fracture incidence was similar among groups. In a subgroup of higher-risk women (n=1,324; femoral neck T-score ≤-3.0 and/or ≥1 moderate or severe or ≥2 mild vertebral fracture[s]), bazedoxifene 20 mg reduced non-vertebral fracture risk versus placebo (37%; P=0.06); combined data for bazedoxifene 20 and 40/20 mg reached statistical significance (34% reduction; P≤.05). Bazedoxifene significantly increased BMD and reduced bone turnover versus placebo (P≤0.05) and was generally safe and well tolerated. Conclusions The findings support a sustained anti-fracture effect of bazedoxifene on new vertebral fractures in postmenopausal osteoporotic women and on non-vertebral fractures in the higher-risk subgroup of women. © International Osteoporosis Foundation and National Osteoporosis Foundation 2011.
Persistent Identifierhttp://hdl.handle.net/10722/163457
ISSN
2015 Impact Factor: 3.445
2015 SCImago Journal Rankings: 1.460
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorSilverman, SLen_US
dc.contributor.authorChines, AAen_US
dc.contributor.authorKendler, DLen_US
dc.contributor.authorKung, AWCen_US
dc.contributor.authorTeglbjærg, CSen_US
dc.contributor.authorFelsenberg, Den_US
dc.contributor.authorMairon, Nen_US
dc.contributor.authorConstantine, GDen_US
dc.contributor.authorAdachi, JDen_US
dc.date.accessioned2012-09-05T05:31:39Z-
dc.date.available2012-09-05T05:31:39Z-
dc.date.issued2012en_US
dc.identifier.citationOsteoporosis International, 2012, v. 23 n. 1, p. 351-363en_US
dc.identifier.issn0937-941Xen_US
dc.identifier.urihttp://hdl.handle.net/10722/163457-
dc.description.abstractSummary In this 2-year extension of a 3-year study, bazedoxifene showed sustained efficacy in preventing new vertebral fractures in postmenopausal women with osteoporosis and in preventing non-vertebral fractures in higherrisk women. Bazedoxifene significantly increased bone mineral density and reduced bone turnover versus placebo and was generally safe and well tolerated. Introduction This study evaluated the efficacy and safety of bazedoxifene for the treatment of postmenopausal osteoporosis over 5 years. Methods A total of 4,216 postmenopausal women with osteoporosis were enrolled in this 2-year extension of a 3-year, randomized, double-blind, placebo-controlled, phase 3 trial. In the core study (N=7,492), subjects received bazedoxifene 20 or 40 mg/day, raloxifene 60 mg/day, or placebo. The raloxifene arm was discontinued after 3 years; subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after 4 years. Five-year findings are reported for bazedoxifene 20 and 40/20 mg and placebo. Endpoints included incidence of new vertebral fractures (primary) and non-vertebral fractures, and changes in bone mineral density (BMD) and bone turnover markers. Results At 5 years, the incidence of new vertebral fractures in the intent-to-treat population was significantly lower with bazedoxifene 20 mg (4.5%) and 40/20 mg (3.9%) versus placebo (6.8%; P<0.05), with relative risk reductions of 35% and 40%, respectively. Non-vertebral fracture incidence was similar among groups. In a subgroup of higher-risk women (n=1,324; femoral neck T-score ≤-3.0 and/or ≥1 moderate or severe or ≥2 mild vertebral fracture[s]), bazedoxifene 20 mg reduced non-vertebral fracture risk versus placebo (37%; P=0.06); combined data for bazedoxifene 20 and 40/20 mg reached statistical significance (34% reduction; P≤.05). Bazedoxifene significantly increased BMD and reduced bone turnover versus placebo (P≤0.05) and was generally safe and well tolerated. Conclusions The findings support a sustained anti-fracture effect of bazedoxifene on new vertebral fractures in postmenopausal osteoporotic women and on non-vertebral fractures in the higher-risk subgroup of women. © International Osteoporosis Foundation and National Osteoporosis Foundation 2011.en_US
dc.languageengen_US
dc.publisherSpringer U K. The Journal's web site is located at http://www.springer.com/medicine/orthopedics/journal/198en_US
dc.relation.ispartofOsteoporosis Internationalen_US
dc.subject.meshAgeden_US
dc.subject.meshBone Density - Drug Effectsen_US
dc.subject.meshBone Density Conservation Agents - Administration & Dosage - Adverse Effects - Therapeutic Useen_US
dc.subject.meshBone Remodeling - Drug Effectsen_US
dc.subject.meshDose-Response Relationship, Drugen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshFemaleen_US
dc.subject.meshFollow-Up Studiesen_US
dc.subject.meshHumansen_US
dc.subject.meshIndoles - Administration & Dosage - Adverse Effects - Therapeutic Useen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshOsteoporosis, Postmenopausal - Complications - Drug Therapyen_US
dc.subject.meshOsteoporotic Fractures - Etiology - Prevention & Controlen_US
dc.subject.meshPlacebosen_US
dc.subject.meshSelective Estrogen Receptor Modulators - Administration & Dosage - Adverse Effects - Therapeutic Useen_US
dc.subject.meshSpinal Fractures - Etiology - Prevention & Controlen_US
dc.subject.meshTreatment Outcomeen_US
dc.titleSustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: Results of a 5-year, randomized, placebo-controlled studyen_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.doi10.1007/s00198-011-1691-1en_US
dc.identifier.pmid21779819-
dc.identifier.scopuseid_2-s2.0-84857366519en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-84857366519&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume23en_US
dc.identifier.issue1en_US
dc.identifier.spage351en_US
dc.identifier.epage363en_US
dc.identifier.isiWOS:000298645700033-
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridSilverman, SL=7202729055en_US
dc.identifier.scopusauthoridChines, AA=16206529000en_US
dc.identifier.scopusauthoridKendler, DL=23970860600en_US
dc.identifier.scopusauthoridKung, AWC=7102322339en_US
dc.identifier.scopusauthoridTeglbjærg, CS=6506033271en_US
dc.identifier.scopusauthoridFelsenberg, D=7006774139en_US
dc.identifier.scopusauthoridMairon, N=43361383300en_US
dc.identifier.scopusauthoridConstantine, GD=7006841339en_US
dc.identifier.scopusauthoridAdachi, JD=26643401000en_US
dc.identifier.citeulike9619363-

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