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Characteristics Associated with Acute-Phase Response following First Zoledronic Acid Infusion in Brazilian Population with Osteoporosis.

ABSTRACT: We aimed to evaluate characteristics associated with acute-phase response (APR) following first zoledronic acid infusion in a Brazilian cohort. This retrospective cohort study enrolled all adults with osteoporosis who underwent a first zoledronic acid infusion at our centre between June 2015 and June 2019. Clinical demographics (age, sex, diabetes, smoking, body mass index, and previous oral bisphosphonate use) and laboratory data (calcium, parathyroid hormone, renal function, and serum 25-hydroxyvitamin D and carboxy-terminal crosslinked telopeptide of type 1 collagen [CTX], both before and after infusion) were compared between patients with and without APR. We evaluated association magnitude between the presence of APR and clinical variables through logistic regression. This study enrolled 400 patients (women, 80%). APR was observed in 24.5% (n = 98) of patients. The mean symptom duration in days was 3.5 ± 2.8. Patients with APR were younger (67 ± 12 vs. 71 ± 11 years; p=0.001), used oral bisphosphonates less frequently (34% × 50%; p=0.005), and had greater baseline CTX (0.535 ng/mL [0.375, 0.697] × 0.430 [0.249, 0.681]; p=0.03) and ΔCTX (-69 [-76; -50] × -54 [-72; -23]; p=0.002) than those without APR. The other variables were similar between the groups. Only ΔCTX was associated (OR, 0.62; 95% CI 0.41-0.98) with APR after accounting for age and bisphosphonate use. APR occurred in 24.5% of the cohort. Younger age and absence of prior oral bisphosphonate use were associated with APR following first zoledronic acid infusion. APR was associated with ΔCTX (but no other variables) after adjusting for these factors.

SUBMITTER: Ferreira BSA

PROVIDER: S-EPMC8731262 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Zoledronic acid (ZOL) as a yearly infusion is effective in reducing fracture risk. An acute-phase reaction (APR), consisting of flu-like symptoms within 3 days after infusion, is commonly seen. The objective of this analysis was to investigate whether APR occurrence influences drug efficacy. This analysis uses data from the 3-year randomized clinical trial, Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly-Pivotal Fracture Trial (HORIZON-PFT). APRs were identified as adverse events within 3 days of first infusion with higher frequency in ZOL than placebo. To compare mean 3-year change in bone mineral density (BMD) in ZOL versus placebo, among women with and without APR, t tests were used. Logistic regression was used to examine the relationship between APR occurrence and odds of incident morphometric vertebral fracture. Cox regression was used to determine the risk of nonvertebral and hip fractures for women with versus without APR. Logistic and Cox models were used to determine the risk of incident fracture in ZOL versus placebo for women with and without an APR. The analysis included 3862 women in the ZOL group and 3852 in placebo, with 42.4% in ZOL versus 11.8% in placebo experiencing an APR. The difference in BMD mean change for ZOL versus placebo was similar for women with and without an APR (all p interaction >0.10). Among ZOL women, those with APR had 51% lower vertebral fracture risk than those without (odds ratio [OR] = 0.49, p < 0.001). A similar but nonsignificant trend was observed for nonvertebral and hip fracture (relative hazard [RH] = 0.82, p = 0.10; RH = 0.70, p = 0.22, respectively). There was a greater treatment-related reduction in vertebral fracture risk among women with APR (OR = 0.19) than those without (OR = 0.38) (p interaction = 0.01). Our results suggest that women starting ZOL who experience an APR will have a larger reduction in vertebral fracture risk with ZOL. © 2021 American Society for Bone and Mineral Research (ASBMR).

Project description:The aim of the present study was to investigate risk factors for the development of an acute-phase response (APR) associated with the initial zoledronic acid (ZA) infusion in patients undergoing surgery, and to assess whether its onset may be reduced by post-dose administration of low-dose methylprednisolone (MP) or acetaminophen. A retrospective study of patients with osteoporosis who attended the departments of orthopedics and endocrinology of a single hospital and received 5 mg ZA was conducted; the patients included surgical and non-surgical cases. A total of 450 ZA-naïve patients who were treated with acetaminophen following ZA infusion were stratified based on whether they suffered APR (APR+) or not (APR-). In addition, 155 of the aforementioned acetaminophen-treated patients (acetaminophen group) were compared with another 32 patients from the orthopedic department who were treated with MP immediately following ZA infusion (MP group). Inflammatory marker levels were significantly higher in APR+ patients than in APR- patients, and the odds ratios of experiencing APR following minimally invasive or open surgery were found to be 3.54 (P<0.001) and 5.71 (P<0.001), respectively, compared with non-surgical intervention after multiple adjustments. C-reactive protein levels prior to dosing were positively correlated with body temperature (r=0.023; P<0.001). The severity of APR also exhibited a negative correlation with 23-hydroxyvitamin D3 levels (r=-0.006; P<0.05). Patients treated with MP following surgery and ZA infusion had a significantly lower incidence of APR compared with those treated with acetaminophen (6.3 vs. 62.6%; P<0.05). However, no significant differences were observed in bone mineral density between the MP and acetaminophen groups at 12 months post-surgery. The results of the present study suggest that surgical trauma serves a key role in ZA-associated APR, and low-dose MP may a suitable post-dose treatment to manage the symptoms of APR in patients undergoing surgery.

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Characteristics Associated with Acute-Phase Response following First Zoledronic Acid Infusion in Brazilian Population with Osteoporosis.

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