Abstract
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
Highlights
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
Exclusion criteria included diseases that may affect bone metabolism or conditions that could interfere with measurement of bone mineral density (BMD), pathologic vertebral fractures, vasomotor symptoms requiring treatment, active or past history of venous thromboembolic events (VTEs), endometrial hyperplasia or carcinoma, abnormal vaginal bleeding, or malignancy within 10 years of the study
The incidence of adverse event (AE), serious AEs, and discontinuations due to AEs in the bazedoxifene treatment groups was not different from that seen in the placebo group (Table 2)
Summary
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. Postmenopausal women experiencing declining levels of endogenous estrogens are disproportionately affected by osteoporosis, which affects one third of women between the ages of 60 and 70 years and two thirds of women 80 years and older [1]. Numerous agents for the prevention and/or treatment of postmenopausal osteoporosis are currently available, including bisphosphonates, estrogen. SERMs, referred to as estrogen agonists/antagonists, are a structurally diverse group of compounds that can confer estrogen receptor agonist or antagonist effects Characteristic Bazedoxifene 20 mg (n = 1886) 40 mg (n = 1872) Raloxifene 60 mg (n = 1849). Placebo (n = 1885) Age, y Mean (SD)
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