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Maturitas. 2013 Sep;76(1):81-7. doi: 10.1016/j.maturitas.2013.06.008. Epub 2013 Jul 18.

Assessment of the safety of long-term bazedoxifene treatment on the reproductive tract in postmenopausal women with osteoporosis: results of a 7-year, randomized, placebo-controlled, phase 3 study.

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  • 1Palacios Institute of Women's Health, Calle Antonio Acuña, 9, 28009 Madrid, Spain. ipalacios@institutopalacios.com

Abstract

OBJECTIVE:

To evaluate the clinical safety of bazedoxifene (BZA) on the reproductive tract in postmenopausal women with osteoporosis over 7 years.

STUDY DESIGN:

This was a second, blinded, 2-year extension of a 3-year, randomized, double-blind, placebo (PBO)- and active-controlled phase 3 trial. In the core study, subjects were randomized to receive BZA 20 or 40mg, raloxifene 60mg, or PBO. During years 4-5, the raloxifene arm was discontinued and subjects receiving BZA 40mg were transitioned to BZA 20mg. Subjects continued to receive BZA 20mg or PBO during years 6-7.

MAIN OUTCOME MEASURES:

The primary endpoint was the incidence of new vertebral fractures at 7 years (reported separately). Reproductive tract safety findings at 7 years are reported here. Endometrial thickness was assessed by transvaginal ultrasonography for subjects in the endometrial safety substudy. Adverse events (AEs) were recorded throughout the study.

RESULTS:

At 7 years, the adjusted mean (±standard error) change in endometrial thickness was similar with BZA and PBO (-0.11 ± 0.21 and 0.07 ± 0.32 mm, respectively). The incidence of endometrial hyperplasia was low (0.1% for both groups). BZA showed significantly lower rates than PBO of endometrial carcinoma (0.1% vs. 0.4%; P=0.020) and vaginitis (6.1% vs. 7.6%; P=0.035). There were more cases of ovarian carcinoma with BZA (n=4 [0.1%]) than PBO (n=0); the difference was not statistically significant. Rates of breast-related and other gynecologic AEs were similar among groups.

CONCLUSIONS:

BZA was associated with a favorable reproductive safety profile in postmenopausal women with osteoporosis over 7 years.

Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

KEYWORDS:

AE; ANCOVA; ANOVA; BMD; BZA; Bazedoxifene; Breast; Clinical safety; ER; EU; Endometrium; European Union; Ovarian; PBO; SERM; Selective estrogen receptor modulator (SERM); TVU; adverse event; analysis of covariance; analysis of variance; bazedoxifene; bone mineral density; estrogen receptor; placebo; selective estrogen receptor modulator; transvaginal ultrasonography

PMID:
23871271
[PubMed - indexed for MEDLINE]
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