| Title | Bazedoxifene effects on the reproductive tract in postmenopausal women at risk for osteoporosis. | | Author(s) | Pinkerton JV, Archer DF, Utian WH, Menegoci JC, Levine AB, Chines AA, Constantine GD | | Institution | From the 1University of Virginia, Charlottesville, VA; 2Eastern Virginia Medical School, Norfolk, VA; 3Rapid Medical Research, Cleveland, OH; 4Pontifícia Universidade Católica de São Paulo, São Paulo, Brazil; and 5Wyeth Research, Collegeville, PA. | | Source | Menopause 2009 Jun 10. | | Abstract | OBJECTIVE:: The aim of this study was to examine the endometrial, ovarian, and breast safety of bazedoxifene, a novel selective estrogen-receptor modulator, in postmenopausal women at risk for osteoporosis.
METHODS:: Healthy postmenopausal women (N = 1,583; mean age, 57.6 y) with lumbar spine or femoral neck bone mineral density T scores between -1 and -2.5 and/or other clinical risk factors for osteoporosis were enrolled in a 24-month, phase 3, randomized, double-blind, placebo- and active-controlled trial. They received daily treatment with bazedoxifene 10, 20, or 40 mg; placebo; or raloxifene 60 mg. Reproductive safety assessments included periodic transvaginal ultrasound measurements of endometrial thickness, ovarian volume, and presence of ovarian cysts; periodic endometrial biopsies; and adverse event reporting.
RESULTS:: Bazedoxifene was not associated with a significant change from baseline in mean endometrial thickness at month 24. The percentage of participants with a change from baseline in endometrial thickness or endometrial thickness greater than 5 mm at month 24 was similar among groups. There was no consensus diagnosis of endometrial hyperplasia or malignancy in the bazedoxifene or raloxifene groups; the rates of other histologic findings, including endometrial polyps, were low (<5%) and similar among groups. No significant between-group differences were found in the change from baseline in ovarian volume, number or size of ovarian cysts, or incidence of ovarian cancer. Reports of breast pain (<4%) and breast cancer (<1%) were low and evenly distributed among groups.
CONCLUSION:: A favorable endometrial, ovarian, and breast safety profile was found after 2 years of treatment with bazedoxifene in healthy, recently postmenopausal women at risk for osteoporosis. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19546825 |
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