Preventing osteoporosis with a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens (BZA/CE).
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.
Clinical Research Center, Helen Hayes Hospital, Route 9W, West Haverstraw, NY 10993, USA. lindsayr@helenhayeshosp.org
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D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D017326:Clinical Trials, Phase III as Topic; D024042:Collagen Type I / Q000378:metabolism / Q000494:pharmacology; D004717:Endometrium / Q000187:drug effects; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D007211:Indoles / Q000008:administration & dosage*; D008593:Menopause / Q000187:drug effects*; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D010455:Peptides / Q000378:metabolism / Q000494:pharmacology; D016032:Randomized Controlled Trials as Topic; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage*; D016896:Treatment Outcome; D014623:Vaginal Diseases / Q000188:drug therapy
D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D004966:Estrogens, Conjugated (USP); D007211:Indoles; D010455:Peptides; D020845:Selective Estrogen Receptor Modulators; C052929:collagen type I trimeric cross-linked peptide; C447119:bazedoxifene