Objective An open study was carried out to evaluate the effect of 2 year of zoledronic acid and tibolone treatment on bone mineral density(BMD),bone remodeling markers,and the risk of fracture in women with postmenopausal osteoporosis(PMOP).Methods In total,567 PMOP women,whose ages ranged 55-64 years,were randomized to 3 groups.185 patients received infusion zoledronic acid 5 mg/year,190 patients received oral tibolone 2.5 mg/d and the rest received oral caltrate and calcitriol (control group,n =192).All of them received oral caltrate 600 mg/d and calcitriol 0.25 μg/day.BMD measurements at the lumbar spine and femoral neck by dual-energy X-ray absorptiometry (DEXA) and the biochemical markers of bone metabolism in serum were performed at the baseline and 6,12,and 24 months.Results Comparing baseline with 24 month's values,BMD increased in zoledronic acid and tibolone group,especially lumbar vertebra (L2-4,P＜ 0.01).But there was no significant deference between zoledronic acid and tibolone group (P ＞ 0.05).Zoledronic acid and tibolone resulted in a significantly greater reduction in bone-specific alkaline phosphatase (BALP),osteocalcin,tartrate-resistant acid phosphatase (TRACP5b),and collagen type Ⅰ C-end peptides (CTX) from baseline all post-baseline time (P＜0.01).There was a significant deference between zoledronic acid and tibolone group in TRACP-5b and CTX(P＜0.05).Treatment with zoledronic acid reduced the risk of new vertebral fracture by 61.9％ during a 2-year period,as compared with placebo (4.3％ in the zoledronic-acid group vs 12.6％ in the control group,P=0.033) and reduced the risk of total fracture by 65.9％ (4.3％ in the zoledronic-acid group,12.6％ in the control group,P =0.004).And in Tibolone group,incidence of total fracture were,significantly lower than in the control group (6.5％ vs 12.6％,P =0.047).There was no serious adverse event occurrence in all patientsm.Conclusions Zoledronic acid could significantly improve BMD and reduce the risk of bone fracture as tibolone.Thus it played an important role in the treatment of postmenopausal osteoporosis.There was no significant difference between these two drugs.Zoledronate can improve the compliance and safety of the patients.However,calcium tablet and vitamin D alone could not prevent the loss of bone.%目的 比较唑来膦酸与替勃龙治疗绝经后骨质疏松症患者骨密度、骨代谢指标的变化及其对骨折发生的影响.方法 选择年龄55 ～ 60岁的PMOP共567例,全部患者均服用钙尔奇D600 mg/d,骨化三醇0.25 μg/d,随机分为唑来膦酸组(A),唑来膦酸5 mg/年,静脉注射(n=185)；替勃龙组(B),替勃龙2.5 mg/d,口服(n=190)；对照组(C),单纯服用钙尔奇D 600 mg/d,骨化三醇0.25 μg/d(n=192).各组均于用药前和用药后6、12、24个月分别用放免法测定骨特异性碱性磷酸酶(BALP)、抗酒石酸酸性磷酸酶5b(tartrate-resistantacid phosphatase,TRACP-5b)；定量夹心酶联免疫法测定骨钙素、Ⅰ型胶原C末端肽(collagentype Ⅰ C-end peptides,CTX),同时进行骨密度测定,胸、腰椎正侧位X线检查及脆性骨折发生情况评估等,并进行统计分析.结果 与C组相比,A组和B组腰椎24个月L2-4骨密度提高6.07％(P＜0.001)和4.28％(P=0.003),股骨颈骨密度提高3.59％(P=0.023)和3.24％ (P=0.042).A、B组间比较,A组高于B组,但差异无统计学意义.A组和B组BALP、骨钙素、TRACP-5b、CTX水平治疗后24个月较治疗前均下降(P＜0.0l)；A、B两组间比较BALP、骨钙素差异无统计学意义(P＞0.05)；TRACP-5b 、CTX有显著性差异(P＜0.01).与C组相比A组新发椎体骨折率下降61.9％ (P=0.033),髋部为0,总的骨折下降65.9％(P=0.004)；B组总的新发骨折发生率下降48.4％(P=0.047).各组均未发现严重不良事件.结论 治疗PMOP唑来膦酸与替勃龙两者均疗效显著,具有升高骨密度及有效地降低骨折发生的作用,而唑来膦酸疗效与替勃龙相似,同时唑来膦酸提高了患者依从性和安全性;单纯服用钙剂和维生素D不能有效地治疗PMOP.
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