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

BMC Musculoskeletal Disorders

Research Article

César E Fernandes¹  Jacques P Brown²  Claus Christiansen³  Santiago Palacios⁴  Ginger D Constantine⁵  Amy B Levine⁵  Arkadi A Chines⁵  Jonathan D Adachi⁶  Annie WC Kung⁷  Charles H Chesnut⁸ 

[1] ABC Medical School, São Paulo, Brazil;CHUL Research Centre, Laval University, Québec City, Québec, Canada;Center for Clinical and Basic Research, Ballerup, Denmark;Instituto Palacios, Salud y Medicina de la Mujer, Madrid, Spain;Pfizer Inc, Collegeville, Pennsylvania, USA;St. Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada;The University of Hong Kong, Queen Mary Hospital, Hong Kong, China;University of Washington, Seattle, Washington, USA;

关键词: Vertebral Fracture;    Raloxifene;    Postmenopausal Osteoporosis;    Femoral Neck Bone Mineral Density;    Selective Estrogen Receptor Modulator;   

DOI  :  10.1186/1471-2474-11-130

 received in 2010-05-07, accepted in 2010-06-22,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundWe 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.MethodsHealthy 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.ResultsOverall, 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.ConclusionBazedoxifene showed a favorable safety and tolerability profile in women with postmenopausal osteoporosis.Trial RegistrationTrial registration number: NCT00205777; Trial registration date: September 16, 2005

【 授权许可】

CC BY   
© Christiansen et al; licensee BioMed Central Ltd. 2010