Effect of combined risedronate and hormone replacement therapies on bone mineral density in postmenopausal women.
Effect of combined risedronate and hormone replacement therapies on bone mineral density in postmenopausal women.
复制标题
利塞膦酸盐和激素替代疗法联合治疗对绝经后妇女骨矿物质密度的影响。
DOI：
10.1210/jcem.86.5.7505
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发表时间：
2001
期刊：
影响因子：
--
通讯作者：
A. Chines
中科院分区：
文献类型：
--
作者：
S. T. Harris;E. Eriksen;Michael Davidson;M. Ettinger;A. Moffett;D. Baylink;C. Crusan;A. Chines
激素替代疗法（HRT）和双膦酸盐在预防和治疗绝经后骨质疏松症中均有效。双膦酸盐和HRT联合治疗可能用于临床实践，关于其疗效和安全性的数据有限。这是一项为期1年、双盲、安慰剂对照的研究，524名绝经后妇女每天单独接受结合马雌激素（0.625 mg）或与利塞膦酸盐（5 mg）联合治疗。未行子宫切除术的妇女根据研究者的判断接受醋酸甲羟孕酮（最多5 mg，每日或周期性）。主要疗效终点是1年时腰椎骨密度（BMD）较基线的百分比变化。还评估了股骨近端和前臂BMD、骨转换标志物、组织学和组织形态计量学的变化。12个月时，两个治疗组腰椎BMD较基线显著增加（P < 0.05）（仅HRT组，4.6%;利塞膦酸钠-HRT联合治疗组，5.2%）;两组间差异无统计学意义。两种治疗均导致12个月时股骨颈（分别为1.8%和2.7%）、股骨转子（3.2%和3.7%）、桡骨远端（1.7%和1.6%）和桡骨中段（0.4%和0.7%）的BMD显著增加。股骨颈和股骨干中段半径组间差异有统计学意义（P < 0.05）。利塞膦酸钠-HRT联合治疗组和单纯HRT治疗组骨转换生化标志物均显著降低，联合治疗组降低幅度更大。骨活检数据显示，两种治疗均显示正常骨结构和正常矿化。观察到骨转换的预期降低，并且在联合治疗组中更大（相对于基线值降低68-79%，P < 0.005）。总体而言，联合治疗的安全性特征与单纯HRT相似，包括骨骼和胃肠道安全性特征。总之，利塞膦酸钠和HRT联合治疗对腰椎BMD的有利影响与HRT单独治疗相似，在股骨颈和中段桡骨略大于但显著大于HRT单独治疗。联合治疗耐受性良好，对骨骼无不良影响。
Both hormone replacement therapy (HRT) and bisphosphonates are efficacious in the prevention and treatment of postmenopausal osteoporosis. Combined therapy with bisphosphonate and HRT is likely to be used in clinical practice, and limited data are available regarding its efficacy and safety. This was a 1-yr, double blind, placebo-controlled study in which 524 postmenopausal women received daily treatment with conjugated equine estrogens (0.625 mg) alone or in combination with risedronate (5 mg). Women who had not undergone hysterectomy received medroxyprogesterone acetate (up to 5 mg, daily or cyclically) at the discretion of the investigator. The primary efficacy end point was the percent change from baseline in mean lumbar spine bone mineral density (BMD) at 1 yr. Changes in BMD at the proximal femur and forearm, bone turnover markers, and histology and histomorphometry were also assessed. At 12 months, significant (P < 0.05) increases from baseline in lumbar spine BMD were observed in both treatment groups (HRT-only, 4.6%; combined risedronate-HRT, 5.2%); the difference between the two groups was not statistically significant. Both therapies led to significant increases in BMD at 12 months at the femoral neck (1.8% and 2.7%, respectively), femoral trochanter (3.2% and 3.7%), distal radius (1.7% and 1.6%), and midshaft radius (0.4% and 0.7%). The differences between groups were statistically significant (P < 0.05) at the femoral neck and midshaft radius. Both combined risedronate-HRT and HRT-only produced significant decreases in the biochemical markers of bone turnover, with somewhat greater decreases in the combined treatment group. Bone biopsy data showed normal bone structure and normal mineralization with either treatment. Expected decreases in bone turnover were observed and were greater in the combined treatment group (68-79% reduction relative to baseline values, P < 0.005). Overall, combined treatment had a safety profile similar to that of HRT-only, including bone and gastrointestinal safety profiles. In conclusion, the combined treatment with risedronate and HRT had a favorable effect on BMD similar to that of HRT alone at the lumbar spine and slightly, but significantly, greater than that of HRT alone at the femoral neck and midshaft radius. The combined treatment was well tolerated, and there were no adverse effects on the skeleton.
影响因子：
158.5
作者：
Grodstein, F;Stampfer, MJ;Hennekens, CH
通讯作者：
Hennekens, CH