Eviö Sirpa, Tiitinen Aila, Laitinen Kalevi, Ylikorkala Olavi, Välimäki Matti J
Department of Obstetrics and Gynecology, Helsinki University Central Hospital, FIN-00029 HUS Helsinki, Finland.
J Clin Endocrinol Metab. 2004 Feb;89(2):626-31. doi: 10.1210/jc.2003-030198.
The aim of the study was to compare alendronate, hormone replacement therapy (HRT), and their combination in treatment of osteoporosis in elderly postmenopausal women. Ninety patients, aged 65-80 yr (mean 71), with a T-score of bone mineral density (BMD) of 2.5 or less at either the lumbar spine or the femoral neck were randomized to receive daily 10 mg alendronate (n = 30), 2 mg estradiol plus 1 mg norethisterone acetate (n = 30) (HRT), or their combination (n = 30) for 2 yr. BMD of the lumbar spine and the upper femur was measured at baseline and after 1 and 2 yr of treatment. Urinary excretion of type I collagen aminoterminal telopeptide as related to creatinine and serum type I procollagen aminoterminal propeptide was assayed at baseline and at 6-month intervals thereafter. Increases of 9.1-11.2% in lumbar spine BMD at 2 yr were similar in the study groups. Only HRT increased femoral neck BMD statistically significantly (P < 0.0001 for a change from baseline) at both 1 (+4.9%; P =NS vs. the other groups) and 2 yr (+5.8%; P < 0.05 vs. the other groups). Total hip BMD increased similarly in all study groups. Percentage reductions in urinary type I collagen aminoterminal telopeptide in the HRT group (60.2-62.7%) were significantly smaller than those in the combination group (78.1-80.4%) (P < 0.0001-0.0069) and the alendronate-only group (72.4-76.1%) (P = 0.047 at 24 months). Serum type I procollagen aminoterminal propeptide decreased less in the HRT group (53.6-59.8%) than in the other groups [73.0-75.0% in the alendronate group (P < 0.001 at 12 months); 67.0-71.5% in the combination group (P < 0.0001 at 12 months, P = 0.013 at 24 months)]. We conclude that in elderly postmenopausal women with osteoporosis, the combination of HRT and alendronate did not offer an extra gain of bone mass over either treatment alone. In terms of BMD changes, the single treatments were equally effective, but the reductions in bone markers were less with HRT than with alendronate.
本研究的目的是比较阿仑膦酸盐、激素替代疗法（HRT）及其联合应用在老年绝经后妇女骨质疏松症治疗中的效果。90例年龄在65 - 80岁（平均71岁）、腰椎或股骨颈骨密度（BMD）T值为2.5及以下的患者被随机分为三组，分别每日接受10 mg阿仑膦酸盐（n = 30）、2 mg雌二醇加1 mg醋酸炔诺酮（n = 30）（HRT）或二者联合治疗（n = 30），为期2年。在基线以及治疗1年和2年后测量腰椎和股骨上段的骨密度。在基线及此后每隔6个月检测与肌酐相关的I型胶原氨基端肽的尿排泄量以及血清I型前胶原氨基端前肽。2年后，各研究组腰椎骨密度增加9.1% - 11.2%，差异相似。仅HRT在1年（增加4.9%；与其他组相比P =无显著性差异）和2年（增加5.8%；与其他组相比P < 0.05）时使股骨颈骨密度有统计学显著增加（与基线相比P < 0.0001）。所有研究组全髋骨密度增加情况相似。HRT组尿I型胶原氨基端肽减少百分比（60.2% - 62.7%）显著低于联合治疗组（78.1% - 80.4%）（P < 0.0001 - 0.0069）和单纯阿仑膦酸盐组（72.4% - 76.1%）（24个月时P = 0.047）。HRT组血清I型前胶原氨基端前肽下降幅度（53.6% - 59.8%）小于其他组[阿仑膦酸盐组为73.0% - 75.0%（12个月时P < 0.001）；联合治疗组为67.0% - 71.5%（12个月时P < 0.0001，24个月时P = 0.013）]。我们得出结论，在患有骨质疏松症的老年绝经后妇女中，HRT与阿仑膦酸盐联合应用在增加骨量方面并不比单独使用任何一种治疗方法更具优势。就骨密度变化而言，单一治疗效果相同，但HRT组骨标志物的降低幅度小于阿仑膦酸盐组。
