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Preventing osteoporosis with a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens (BZA/CE)

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Abstract

Hormone therapy classically consists of an estrogen with an added progestin; however, concerns have been raised about the potential negative effects of progestin. The recent realization that estrogen agonist–antagonists or selective estrogen receptor modulators might be paired with estrogens instead of a progestin has led to the development of a novel form of menopausal therapy called tissue selective estrogen complex (TSEC). A TSEC is the pairing of a selective estrogen receptor modulator (SERM) with estrogen(s). The TSEC containing conjugated estrogens (CE) and the SERM, bazedoxifene (BZA), has reached clinical development. This short review outlines the effects of this particular TSEC, which maintains or increases bone mass in women at high risk for osteoporosis, and has clinical qualities of a promising new menopausal therapy. Randomized, double-blind, placebo-controlled phase 3 trials in postmenopausal women showed that, in addition to bone preservation, BZA/CE was shown to relieve hot flushes and treat vulvar–vaginal atrophy and its symptoms, with a good safety and tolerability profile.

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Acknowledgment

The author acknowledges medical writing support provided by Kathleen Ohleth, Ph.D., at Precise Publications, LLC, which was funded by Pfizer Inc.

Conflicts of interest

Dr. Lindsay is a consultant for Eli Lilly and Amgen and is a speaker for Eli Lilly, Novartis, and Amgen. Pfizer provided funding for medical writing support of the manuscript through a third party.

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Authors and Affiliations

  1. Clinical Research Center, Helen Hayes Hospital, Route 9W, West Haverstraw, NY, 10993, USA

    R. Lindsay

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  1. R. Lindsay
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Correspondence to R. Lindsay.

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Contributorship

Dr. Lindsay was the sole contributor to the concept and content direction of the paper and critically reviewed and revised the draft for important intellectual content and approved the final draft to be published, thus also meeting authorship criteria of the International Council of Medical Journal Editors. Dr. Ohleth provided medical writing support under the direction of Dr. Lindsay. Dr. Lindsay participated in the clinical trial for this TSEC funded by Wyeth.

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Lindsay, R. Preventing osteoporosis with a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens (BZA/CE). Osteoporos Int 22, 447–451 (2011). https://doi.org/10.1007/s00198-010-1440-x

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  • DOI: https://doi.org/10.1007/s00198-010-1440-x

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