CE/BZA effects on bone and quality of life in European postmenopausal women: a pooled analysis

<p><b>Objectives:</b> To evaluate the efficacy of conjugated estrogens/bazedoxifene (CE/BZA) on bone mineral density (BMD), bone turnover markers (BTM), and menopause-specific quality of life (MENQOL) in European women.</p> <p><b>Methods:</b> Data through 12 months were pooled from two double-blind, randomized, controlled trials in non-hysterectomized postmenopausal women who received CE/BZA or placebo. Women from European study sites with evaluable BMD (<i>n</i> = 60), BTM (<i>n</i> = 56), and MENQOL questionnaire (<i>n</i> = 236) data were included and compared with 1523 women from US study sites (<i>n</i> = 730 with evaluable data for bone outcomes).</p> <p><b>Results:</b> At month 12, CE 0.45 mg/BZA 20 mg and CE 0.625 mg/BZA 20 mg, respectively, significantly improved BMD (adjusted difference vs. placebo) in lumbar spine (2.5%, 2.9%; both <i>p</i> ≤ 0.011) and total hip (1.7%, 2.2%, both <i>p</i> ≤ 0.002), significantly improved serum BTMs (osteocalcin: –31.1%, –33.1%; C-telopeptide: –48.5%, –36.8%) vs. placebo (osteocalcin: 6.7%, C-telopeptide: 4.2%; all <i>p</i> < 0.001), and significantly improved MENQOL vasomotor function scores (–2.1, –2.2) vs. placebo (–0.7; both <i>p</i> < 0.001). No significant treatment × subpopulation interactions were observed for any of the outcomes.</p> <p><b>Conclusions:</b> Twelve-month CE/BZA treatment prevented bone loss and improved vasomotor function in European postmenopausal women. Findings were similar to those in the subpopulation of women enrolled at US study sites.</p

Correction: The Influence of Age and Sex on Genetic Associations with Adult Body Size and Shape: A Large-Scale Genome-Wide Interaction Study.

The arcOGEN Consortium should be listed as an author of this article. They contributed to the genome-wide association study results presented in this work. They should be listed in the author byline at position 292 and affiliated with The Arthritis Research UK Osteoarthritis Genetics Consortium. They should also be included in the footnote designating consortia which is underneath the author affiliation list in the PDF version of the article, and in the S2 Text. Please view the correct S2 Text below, containing correct consortia members. S2 Text. Consortia members and extended acknowledgments. https://doi.org/10.1371/journal.pgen.1006166.s001 (DOCX) [This corrects the article DOI: 10.1371/journal.pgen.1005378.]