Meunier P J, Confavreux E, Tupinon I, Hardouin C, Delmas P D, Balena R
Department of Rheumatology & Bone Disease, Edouard Herriot Hospital, Lyon, France.
J Clin Endocrinol Metab. 1997 Sep;82(9):2784-91. doi: 10.1210/jcem.82.9.4073.
The objective of the study was to evaluate the effects of cyclical therapy with etidronate and calcium on spinal and femoral bone loss in the early post menopausal period. Fifty-four women, 53 +/- 2.8 yr old (mean +/- SD) and 2.3 +/- 1.3 yr post menopause received oral doses of either 400 mg/day etidronate for 2 weeks followed by 500 mg/day elemental calcium for 11 weeks, or placebo for 14 days followed by calcium for 11 weeks, repeated over a total of 24 months. A statistically significant increase in spinal bone mineral density (BMD) was observed after 6 months in the etidronate group. At 2 yr, the mean treatment differences in spinal and femoral neck BMD were +2.93% (P < 0.02) and 2.02% (P < 0.03), respectively. Serum osteocalcin and urinary crossLaps/creatinine excretion were decreased significantly by etidronate. Etidronate was well tolerated with a safety profile similar to that of placebo. Thirty-seven women participated in a 1-yr open-label follow-up study. Twelve months after treatment withdrawal, spinal BMD in the former etidronate group decreased by 1.43% and serum osteocalcin and urinary crossLaps returned to pretreatment values. In conclusion, cyclical etidronate is an effective therapy for the prevention of both trabecular and cortical bone loss in the early menopause and has a good safety profile.
本研究的目的是评估依替膦酸二钠和钙的周期性疗法对绝经后早期脊柱和股骨骨质流失的影响。54名年龄在53±2.8岁（均值±标准差）且绝经后2.3±1.3年的女性，口服剂量为每天400毫克依替膦酸二钠，持续2周，随后每天服用500毫克元素钙，持续11周；或服用安慰剂14天，随后服用钙11周，共重复24个月。依替膦酸二钠组在6个月后观察到脊柱骨矿物质密度（BMD）有统计学意义的增加。在2年时，脊柱和股骨颈BMD的平均治疗差异分别为+2.93%（P<0.02）和2.02%（P<0.03）。依替膦酸二钠显著降低了血清骨钙素和尿交联C末端肽/肌酐排泄。依替膦酸二钠耐受性良好，安全性与安慰剂相似。37名女性参与了一项为期1年的开放标签随访研究。停药12个月后，前依替膦酸二钠组的脊柱BMD下降了1.43%，血清骨钙素和尿交联C末端肽恢复到治疗前水平。总之，周期性依替膦酸二钠是预防绝经早期小梁骨和皮质骨流失的有效疗法，且安全性良好。
