Trial reportCalcified tissue international2021
Acute Phase Reactions After Intravenous Infusion of Zoledronic Acid in Japanese Patients with Osteoporosis: Sub-analyses of the Phase III ZONE Study.
Trial report in Calcified tissue international, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01522521 (Phase 3 Study of AK156 in Primary Osteoporosis Patients), which is not on this map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 3 Study of AK156 in Primary Osteoporosis Patients
Who cites it
15 citing papers in PubMed.
- Acute-phase reaction and fracture outcomes from zoledronic acid: a systematic review and meta-analysis.Journal of bone and mineral metabolism · 2026Article
- Papulovesicular eruption after administration of zoledronic acid: A rare cutaneous manifestation of an acute phase reaction.JAAD case reports · 2026Article
- Smartphone-based patient-reported outcome of acute phase reaction after zoledronic acid infusion and prediction algorithm: a multicenter, prospective cohort study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- Challenges in Sequential Antiresorptive Therapy After Long-Term Denosumab Discontinuation: A Case Report and Narrative Review of the Literature.Journal of clinical medicine · 2026Review
- Addisonian crisis following osteoprotective therapy in a patient with secondary adrenal insufficiency.JCEM case reports · 2026Article
- Effect of precise health management combined with physical rehabilitation on bone biomarkers in senile osteoporosis patients.Scientific reports · 2025Observational
- Modulatory efficacy of bone metabolism and safety of denosumab versus zoledronic acid in the treatment of bone and joint osteoporosis in elderly men.Frontiers in pharmacology · 2025Article
- Preventing OsteoPorosis in Spinal Cord Injury (POPSCI) Study-Early Zoledronic Acid Infusion in Patients with Acute Spinal Cord Injury.Calcified tissue international · 2024Article
- Change in body temperature, not acute-phase reaction, predict anti-Osteoporosis efficacy after the first administration of Zoledronic acid: a prospective observational cohort study.BMC musculoskeletal disorders · 2024Observational
- The impact of acute-phase reaction on mortality and re-fracture after zoledronic acid in hospitalized elderly osteoporotic fracture patients.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023Article
- Lessons learned from long-term side effects after zoledronic acid infusion following denosumab treatment: a case report and review of the literature.Journal of medical case reports · 2022Review
- Predicting the acute-phase response fever risk in bisphosphonate-naive osteoporotic patients receiving their first dose of zoledronate.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022Article
- Two-year effectiveness of zoledronic acid with or without eldecalcitol in Japanese patients with osteoporosis: A randomized prospective study.Osteoporosis and sarcopenia · 2022Article
- Association between vitamin D and zoledronate-induced acute-phase response fever risk in osteoporotic patients.Frontiers in endocrinology · 2022Article
- Investigation of the Antiangiogenic Properties of Zoledronic Acid by Using Chorioallantoic Membrane Model.Dose-response : a publication of International Hormesis SocietyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
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).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.