Wasnich Richard D, Bagger Yu Z, Hosking David J, McClung Michael R, Wu Mei, Mantz Ann Marie, Yates John J, Ross Philip D, Alexandersen Peter, Ravn Pernille, Christiansen Claus, Santora Arthur C
Radiant Research-Honolulu, Honolulu, HI 96814, USA.
Menopause. 2004 Nov-Dec;11(6 Pt 1):622-30. doi: 10.1097/01.gme.0000123641.76105.b5.
To compare bone mineral density (BMD) and bone turnover changes after therapy withdrawal in postmenopausal women treated with alendronate or estrogen-progestin.
In this randomized, blinded, multinational, placebo-controlled trial, 1,609 healthy postmenopausal women ages 45 to 59 years were assigned to receive alendronate, placebo, or open-label estrogen-progestin (conjugated equine estrogens plus medroxyprogesterone acetate or a cyclic regimen of 17 beta-estradiol, norethisterone acetate and estradiol). Of the original women, one third after year 2 and one third after year 4 were switched from alendronate to placebo, while remaining blinded to treatment assignment. The women taking estrogen-progestin in years 1 to 4 were followed off therapy in years 5 and 6. BMD at the lumbar spine and hip and biochemical markers of bone turnover were measured.
The treatment groups described in the current report represent 860 women at baseline; 481 women entered year 5, and 430 completed 6 years. BMD steadily decreased in the placebo group during all 6 years. In contrast, spine and hip BMD increased during the first 4 years in the groups receiving daily continuous alendronate 5 mg and estrogen-progestin. During years 5 and 6, BMD decreased at the lumbar spine -2.42% (95% CI = -4.10, -0.74) and total hip -1.09% (-2.60, 0.41) in the group previously treated with alendronate 5 mg for 4 years. In comparison, large BMD decreases were observed at the spine [-7.69% (-8.96, -6.41)] and total hip [-5.16% (-6.30, -4.01)] among women who had received estrogen-progestin for 4 years.
Alendronate produces greater residual skeletal effects than estrogen-progestin after therapy discontinuation.
比较阿仑膦酸钠或雌激素 - 孕激素治疗的绝经后女性停药后骨密度（BMD）和骨转换的变化。
在这项随机、双盲、多国、安慰剂对照试验中，1609名年龄在45至59岁的健康绝经后女性被分配接受阿仑膦酸钠、安慰剂或开放标签的雌激素 - 孕激素（结合马雌激素加醋酸甲羟孕酮或17β - 雌二醇、醋酸炔诺酮和雌二醇的周期方案）。在最初的女性中，三分之一在第2年后和三分之一在第4年后从阿仑膦酸钠改为安慰剂，同时对治疗分配保持盲态。在第1至4年服用雌激素 - 孕激素的女性在第5年和第6年停止治疗并进行随访。测量腰椎和髋部的骨密度以及骨转换的生化标志物。
本报告中描述的治疗组在基线时有860名女性；481名女性进入第5年，430名完成6年。安慰剂组在所有6年中骨密度稳步下降。相比之下，接受每日5毫克连续阿仑膦酸钠和雌激素 - 孕激素治疗的组在最初4年中脊柱和髋部骨密度增加。在第5年和第6年，先前接受4年5毫克阿仑膦酸钠治疗的组中，腰椎骨密度下降2.42%（95%CI = -4.10， -0.74），全髋骨密度下降1.09%（-2.60，0.41）。相比之下，接受4年雌激素 - 孕激素治疗的女性中，脊柱骨密度大幅下降[-7.69%（-8.96， -6.41）]，全髋骨密度下降[-5.16%（-6.30， -4.01）]。
停药后，阿仑膦酸钠比雌激素 - 孕激素产生更大的骨骼残余效应。
