Zoledronic acid efficacy and safety over five years in postmenopausal osteoporosis
Zoledronic acid efficacy and safety over five years in postmenopausal osteoporosis
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DOI：
10.1007/s00198-007-0367-3
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发表时间：
2007-09-01
影响因子：
4
通讯作者：
Garnero, P.
中科院分区：
文献类型：
--
作者：
Devogelaer, J. P.;Brown, J. P.;Garnero, P.
在一项涉及119名绝经后妇女的5年研究中，唑来膦酸4 mg每年一次给药2年、3年或5年耐受性良好，没有证据表明骨转换过度减少或任何安全性信号。BMD显著增加。骨转换标志物从基线下降，并保持在绝经前referencesrange.Introduction核心研究完成后，连续两个，2年，开放标签扩展调查的疗效和安全性唑来膦酸4毫克超过5年绝经后osteoporosis.Methods在核心研究中，患者接受1至4毫克唑来膦酸或安慰剂。在第一个扩展期，大多数患者接受4 mg/年，然后患者进入第二个扩展期，接受4 mg/年或仅钙。根据接受活性药物治疗的年数（2、3或5年）将患者分为3个亚组。BMD和骨转换标志物（骨ALP和CTX-I）的变化进行了assessed.Results所有亚组显示BMD大幅增加，骨标志物减少。到核心研究结束时，37.5%的患者显示骨ALP水平降低不理想（< 30%）。在扩展期间的后续研究药物给药后，无证据表明骨转换标志物进行性降低。此外，治疗中止后标志物水平的增加表明骨重塑capability.Conclusions保存这项研究表明，唑来膦酸4毫克一年一次耐受性良好，有效地减少生物标志物超过5年。然而，对骨标志物变化的详细分析表明，该药物方案在三分之一的患者中导致重塑活动的减少不足。
In a 5-year study involving 119 postmenopausal women, zoledronic acid 4 mg given once-yearly for 2, 3 or 5 years was well tolerated with no evidence of excessive bone turnover reduction or any safety signals. BMD increased significantly. Bone turnover markers decreased from baseline and were maintained within premenopausal reference ranges.Introduction After completion of the core study, two consecutive, 2-year, open-label extensions investigated the efficacy and safety of zoledronic acid 4 mg over 5 years in postmenopausal osteoporosis.Methods In the core study, patients received 1 to 4 mg zoledronic acid or placebo. In the first extension, most patients received 4 mg per year and then patients entered the second extension and received 4 mg per year or calcium only. Patients were divided into three subgroups according to years of active treatment received ( 2, 3 or 5 years). Changes in BMD and bone turnover markers ( bone ALP and CTX-I) were assessed.Results All subgroups showed substantial increases in BMD and decreases in bone markers. By the end of the core study, 37.5% of patients revealed a suboptimal reduction (< 30%) of bone ALP levels. After subsequent study drug administration during the extensions, there was no evidence of progressive reduction of bone turnover markers. Furthermore, increased marker levels after treatment discontinuation demonstrates preservation of bone remodelling capacity.Conclusions This study showed that zoledronic acid 4 mg once-yearly was well tolerated and effective in reducing biomarkers over 5 years. Detailed analysis of bone marker changes, however, suggests that this drug regimen causes insufficient reduction of remodelling activity in one third of patients.