Abstract
In a clinical trial involving Japanese patients with osteoporosis, post hoc analyses were performed to evaluate the incidence of acute phase reactions (APRs) after infusion of zoledronic acid (ZOL). The results highlighted differences in baseline factors between patients with vs without APRs. Changes in efficacy indicators such as bone turnover markers (BTMs) also showed significant differences. We, therefore, investigated the factors involved in the development of APRs in Japanese patients treated with a once-yearly intravenous infusion of ZOL 5 mg for 2 years by assessing the relation between APRs and efficacy. APRs reported in patients with primary osteoporosis from the ZONE study were analyzed post hoc. Baseline factors were compared in patients with vs without APRs, and changes in BTMs and bone mineral density (BMD) were also investigated. In the ZOL group, 51.2% (169/330) of patients developed APRs after the first infusion and 12.3% (33/268) after the second infusion. Comparison of baseline factors showed that patients without APRs in the ZOL group had a significantly higher neutrophil/lymphocyte ratio, lower serum levels of procollagen type I N-terminal propeptide, older age, and higher likelihood of prior bisphosphonate use vs patients with APRs. Patients with APRs showed significantly higher increases in total hip BMD at 6 and 12 months and larger reductions in BTMs vs patients without APRs. Patient profiles differed significantly between patients with vs without APRs, with APRs after the first infusion of ZOL being related to increases in total hip BMD and suppression of BTMs.This study is registered with ClinicalTrials.gov (identifier: NCT01522521; January 31, 2012).
Highlights
Various types of drugs for osteoporosis have been available in the Japanese market, and bisphosphonates are used as a first-line treatment for patients with osteoporosis [1]
Patient demographics and baseline factors of the analysis set were identical to those reported in the published ZOledroNate treatment in Efficacy to osteoporosis (ZONE) study [7]
Since 25(OH)D levels at the first infusion did not alter the expression of acute phase reactions (APRs), we considered that analysis after the second infusion was not necessary
Summary
Various types of drugs for osteoporosis have been available in the Japanese market, and bisphosphonates are used as a first-line treatment for patients with osteoporosis [1]. In a previous clinical study—the Health Outcomes and Reduced Incidence with Zoledronic acid Once YearlyPivotal Fracture Trial (HORIZON-PFT)—treatment with ZOL for up to 3 years showed a significant and sustained decrease in the risk of vertebral, hip, and other osteoporotic fractures and was well tolerated in patients with osteoporosis [4]. We investigated the association of sex with the development of APRs. The results showed that the mean age was lower in the APR+ group vs the APR− group (p = 0.031). Significant differences between the APR+ and APR− groups were noted with regard to the neutrophil count (p < 0.001) and lymphocyte count (p < 0.001) in the differential leukocyte count, with a significantly lower NLR in the APR+ group. No significant differences were observed in serum 25(OH)D levels at baseline in both APR groups. Since 25(OH)D levels at the first infusion did not alter the expression of APRs, we considered that analysis after the second infusion was not necessary
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