Rubinacci Alessandro, Peruzzi Elena, Modena Alberto Bacchi, Zanardi Ettore, Andrei Bruno, De Leo Vincenzo, Pansini Francesco Saverio, Quebe-Fehling Erhard, de Palacios Patricia Ibarra
Bone Metabolic Unit, Scientific Institute, San Raffaele Hospital, Milan, Italy.
Menopause. 2003 May-Jun;10(3):241-9. doi: 10.1097/00042192-200310030-00012.
To assess the efficacy of a continuous-combined transdermal patch (estradiol/ norethisterone acetate [E(2)/NETA] 25/125; Estragest TTS, Novartis, Basel, Switzerland) in the reduction of bone loss in postmenopausal women.
In a 96-week, double-blind, randomized, multicenter, parallel study, 124 healthy women with an intact uterus more than 4 years after menopause received either transdermal continuous-combined E(2)/NETA (0.025/0.125 mg/day) or placebo patch for 24 treatment cycles; diet was normalized for calcium intake. Lumbar spine bone mineral density (BMD) ranged from 0.969 to 0.805 g/cm2 with a mean annual BMD decrement ranging from 3% to 8% within the last 24 months. BMD at lumbar spine L(2)-L(4) (postero-anterior) and femur were assessed by dual energy x-ray absorptiometry after 6, 12, and 24 cycles. Efficacy variables included measurement of biochemical markers of bone turnover (3, 6, 12, and 24 months).
BMD at lumbar spine was significantly higher at all time points in the E(2)/NETA group than in the placebo group (P < 0.0001). Significant increases in BMD (P < 0.0008) from baseline were observed at all sites after 24 months in the E(2)/NETA group compared with placebo, which demonstrated a decrease from baseline. At endpoint, statistically significant decrements in the values of bone remodeling markers were observed (P < 0.05) with E(2)/NETA.
E(2)/NETA 25/125 Estragest TTS was more effective than placebo in reducing the activation frequency of bone remodeling and in preventing bone loss at the spine and hip. Effects on the hip were similar to those observed for higher doses of estrogen.
评估连续联合经皮贴剂（雌二醇/醋酸炔诺酮[E(2)/NETA]25/125；瑞士巴塞尔诺华公司的Estragest TTS）减少绝经后女性骨质流失的疗效。
在一项为期96周的双盲、随机、多中心、平行研究中，124名绝经后4年以上子宫完好的健康女性接受经皮连续联合E(2)/NETA（0.025/0.125毫克/天）或安慰剂贴剂治疗24个周期；饮食中钙摄入量标准化。腰椎骨矿物质密度（BMD）在0.969至0.805克/平方厘米之间，过去24个月内平均每年BMD下降幅度在3%至8%之间。在第6、12和24个周期后，通过双能X线吸收法评估腰椎L(2)-L(4)（前后位）和股骨的BMD。疗效变量包括骨转换生化标志物的测量（第3、6、12和24个月）。
在所有时间点，E(2)/NETA组的腰椎BMD均显著高于安慰剂组（P<0.0001）。与安慰剂组相比，E(2)/NETA组在24个月后所有部位的BMD均较基线有显著增加（P<0.0008），而安慰剂组BMD较基线下降。在终点时，观察到E(2)/NETA组骨重塑标志物值有统计学意义的下降（P<0.05）。
E(2)/NETA 25/125 Estragest TTS在降低骨重塑激活频率以及预防脊柱和髋部骨质流失方面比安慰剂更有效。对髋部的影响与高剂量雌激素观察到的效果相似。
