The effects of bazedoxifene on mammographic breast density in postmenopausal women with osteoporosis
The effects of bazedoxifene on mammographic breast density in postmenopausal women with osteoporosis
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DOI：
10.1097/gme.0b013e3181a7fb1e
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发表时间：
2009-11-01
影响因子：
2.7
通讯作者：
Helzner, Eileen
中科院分区：
文献类型：
--
作者：
Harvey, Jennifer A.;Holm, Mary K.;Helzner, Eileen
目的：本研究旨在评估乳腺钼靶摄影乳腺密度的定量变化后，24个月的治疗与苯多昔芬与雷洛昔芬或安慰剂在绝经后妇女骨质疏松症。方法：这是一个回顾性的，辅助研究的一个子集的妇女参加了一个多中心，双盲，随机，安慰剂和活性对照的3期试验评估苯多昔芬治疗绝经后骨质疏松症。参与者被随机分配接受巴多昔芬20或40 mg，雷洛昔芬60 mg或安慰剂，每日一次，持续3年。为了有资格进行乳腺密度评估，参与者必须年满62岁或更年轻，并完成24个月的治疗，在基线和24个月时进行乳房X光检查。每个参与者的原始乳房X线照片对（左头尾视图）由放射科医生数字化并分析。使用交互式阈值分割的乳房X光片，乳腺密度进行测量，并使用一个有效的软件program.Results：乳房X光片对获得444名参与者的百分比密度。各组的基线和人口统计学特征相似（平均年龄，58.7岁）。24个月后，乳腺密度较基线的平均百分比变化较低（巴多昔芬20 mg，-1.2%;巴多昔芬40 mg，-0.4%;雷洛昔芬60 mg，-0.5%;安慰剂，-0.2%），组间无显著差异。巴多昔芬治疗2年并不影响绝经后骨质疏松妇女人群中与年龄相关的乳腺密度变化。巴多昔芬20或40 mg组乳腺密度的变化与雷洛昔芬60 mg或安慰剂组相似。
Objective: This study aimed to assess quantitative changes in mammographic breast density after 24 months of therapy with bazedoxifene compared with raloxifene or placebo in postmenopausal women with osteoporosis.Methods: This was a retrospective, ancillary study of a subset of women enrolled in a multicenter, double-blind, randomized, placebo- and active-controlled phase 3 trial evaluating bazedoxifene for the treatment of postmenopausal osteoporosis. Participants were randomly assigned to receive bazedoxifene 20 or 40 mg, raloxifene 60 mg, or placebo once daily for 3 years. To be eligible for breast density evaluation, participants had to be 62 years or younger and completed 24 months of treatment, with mammograms at baseline and 24 months. Original mammogram pairs (left craniocaudal views) for each participant were digitized and analyzed by a radiologist. Breast density was measured using interactive thresholding to segment the mammogram, and percent density was determined using a validated software program.Results: Mammogram pairs were obtained from 444 participants. Baseline and demographic characteristics were similar among groups (mean age, 58.7 y). After 24 months, the mean percent changes in breast density from baseline were low (bazedoxifene 20 mg, -1.2%; bazedoxifene 40 mg, -0.4%; raloxifene 60 mg, -0.5%; placebo, -0.2%) and not significantly different among groups.Conclusions: Treatment with bazedoxifene for 2 years did not affect age-related changes in breast density in this population of postmenopausal women with osteoporosis. The changes in breast density with bazedoxifene 20 or 40 mg were similar to those with raloxifene 60 mg or placebo.