The Change in Body Temperature, Not Acute-Phase Reaction, Predicts anit-Osteoporosis Efficacy after the First Administration of Zoledronic Acid in a self-control study

Abstract Background: Acute-phase reactions (APRs) are common among people who are 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 APR and ZOL efficacy remains unclear. Methods： This study was a self pre - post control study involving postmenopausal women with osteoporosis in Shanghai, China, for 1 year. A total of 108 patients withan 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 CTX and PINP, and bone mineral density (BMD) were collected. Results： 1) The results did not show a relationship between the 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 BMD of LS at Month 6 and Month 12 (r=0.304 P<0.05, r=0.387 P<0.01). 2) This effect was mainly mediated by changes in serum CTX (b=0.046, 95% CI [0.0010-0.0091]). 3) TheROC curve showed that when T increased by 1.95°C, the sensitivity and specificity of judging the clinically important change in LS BMD after 1 year were the best. Conclusions: In this study, we tested the hypothesis that people with elevated body T after initial ZOL treatment had greater BMD improvements and better outcomes.