背景:急性期反应(APRs)在首次使用唑来膦酸(ZOL)治疗的人群中很常见。目前的观点是ZOL引起的APRs及其功效均与甲羟戊酸途径有关。然而,APRs与ZOL疗效之间的关系尚不清楚.
方法:这是一项前瞻性观察性队列研究,涉及上海绝经后骨质疏松症妇女,中国,1年。总共108例患者,平均年龄为67.4±5.8岁,首次接受5mg静脉ZOL治疗。关于人口特征的数据,APRs,血细胞计数,骨转换标记,包括C端肽胶原交联(CTX)和1型胶原的N端前肽(PINP),收集骨密度(BMD)。
结果:(1)结果未揭示APRs与骨转换标志物和BMD变化之间的关系,但显示给药后3天内体温(T)的变化与12个月时LS的BMD变化呈正相关(β=0.279P=0.034)。(2)这种作用主要由血清CTX的变化介导(b=0.046,95%CI[0.0010-0.0091])。(3)ROC曲线显示,当T升高1.95℃时,我们优化了1年后识别LSBMD临床重要变化的敏感性和特异性.
结论:在这项研究中,我们检验了以下假设:初次ZOL治疗后,体T升高的患者BMD改善更大,结局更好.
背景:NCT,NCT03158246。注册18/05/2017。
BACKGROUND: Acute-phase reactions (APRs) are common among people treated for the first time with zoledronate (ZOL). The current view is that both the APRs caused by ZOL and its efficacy are related to the mevalonic acid pathway. However, the relationship between APRs and ZOL efficacy remains unclear.
METHODS: This was a prospective observational cohort study involving postmenopausal women with osteoporosis in Shanghai, China, for 1 year. A total of 108 patients with an average age of 67.4 ± 5.8 years were treated with 5 mg intravenous ZOL for the first time. Data on demographic characteristics, APRs, blood counts, bone turnover markers, including C-telopeptide collagen crosslinks (CTX) and N-terminal propeptide of type 1 collagen (PINP), and bone mineral density (BMD) were collected.
RESULTS: (1) The results did not reveal a relationship between APRs and changes in bone turnover markers and BMD but showed that changes in body temperature (T) within 3 days after administration were positively correlated with changes in the BMD of the LS at Month 12 (β = 0.279 P = 0.034). (2) This effect was mediated mainly by changes in serum CTX (b = 0.046, 95% CI [0.0010-0.0091]). (3) The ROC curve revealed that when T increased by 1.95 °C, the sensitivity and specificity of identifying clinically important changes in LS BMD after 1 year were optimized.
CONCLUSIONS: In this study, we tested the hypothesis that people with elevated body T after initial ZOL treatment had greater improvements in BMD and better outcomes.
BACKGROUND: NCT, NCT03158246. Registered 18/05/2017.