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

Abstract

Objectives: 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.

Methods: 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 (n = 60), BTM (n = 56), and MENQOL questionnaire (n = 236) data were included and compared with 1523 women from US study sites (n = 730 with evaluable data for bone outcomes).

Results: 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 p ≤ 0.011) and total hip (1.7%, 2.2%, both p ≤ 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 p < 0.001), and significantly improved MENQOL vasomotor function scores (–2.1, –2.2) vs. placebo (–0.7; both p < 0.001). No significant treatment × subpopulation interactions were observed for any of the outcomes.

Conclusions: 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.

Keywords:

• Conjugated estrogens
• bazedoxifene
• menopause
• bone mineral density
• vasomotor

Acknowledgements

Medical writing support was provided by Karen Dougherty, PhD of Peloton Advantage and was funded by Pfizer Inc.

Conflict of interest

P. Hadji has acted as a consultant and speaker for Abbott, Eli Lilly, MSD, Novartis, and Pfizer. K. A. Ryan, C. R. Yu, and B. S. Komm are employees and shareholders of Pfizer. S. Mirkin was an employee of Pfizer at the time of this data analysis.

Source of funding

This study was sponsored by Pfizer Inc.