Abstract

Objective: To investigate whether sequential regimen such as traditional anti-reabsorption medications followed by zoledronic acid could reduce the side effects after initiation of zoledronic acid in postmenopausal osteoporosis patients. Methods: A total of 156 postmenopausal osteoporosis patients who presented at our osteoporosis outpatient clinic were enrolled in this study. They were randomly divided into four groups: the control group, alendronate group, calcitonin group, and raloxifene group. All participants were treated with Caltrate 600 mg per day and calcitriol 0.25 ug per day as a baseline treatment, followed by administrating 5 mg/100 mL of zoledronic acid intravenously for one single time three months afterwards. During the abovementioned course of three months, the alendronate group received 70 mg of alendronate sodium orally once a week, the calcitonin group received nasal spray form of salmon calcitonin 10iu daily, the raloxifene group received 60mg of raloxifene orally daily, and the control group received nothing but only the baseline treatment. We tested parameters such as β-cross, blood calcium level, renal function both pre and post zoledronic acid treatment. We also documented those side effects that typically occurred within one week of treatment initiation, which included the proportion, severity, onset time, and duration of the fever, demand for pain medication, severity of bone and joint pain, flu-like symptoms, arrhythmia, blood calcium level, and kidney function impairment. We also evaluated how willing the patients were to receive a second dose of zoledronic acid. Then we did comparative analysis between control group and sequential group. Results: The side effects such as fever, bone and joint pain, flu-like symptoms after zoledronic acid treatment in alendronate group and calcitonin group were all significantly lower than that in control group, while raloxifene group showed no significant difference compared to that in the control group. The proportions of patients who needed NSAIDs in the alendronate group and the calcitonin group were significantly lower than that in control group. However, the raloxifene group showed no significant difference in the NSAIDs demand from that of the control group. The percentages of patients who consented to a second dose of zoledronate therapy in the alendronate, calcitonin and raloxifene groups were significantly higher than that in the control group. Conclusions: Sequential treatment with alendronate sodium or calcitonin can significantly reduce the side effects such as fever, bone/joint pain, flu-like symptoms caused by first-time zoledronic acid therapy. Raloxifene sequential treatment does not seem to have decreased or increased the side effects of zoledronic acid treatment. Also, sequential treatment can improve the patient compliance with a second dose of zoledronic acid.

Highlights

  • Anti-reabsorption medications are most widely used for treating osteoporosis

  • This study aims to investigate whether sequential regimen, namely, traditional anti-reabsorption medications followed by zoledronic acid could reduce or mitigate the acute side effects brought by zoledronic acid administration in postmenopausal patients with osteoporosis

  • Et al carried out a multicenter international trial involving 7765 postmenopausal women with osteoporosis to explore the characteristics of the acute-phase response (APR) after zoledronic acid, and found that 42.7% of the zoledronic acid group had a fever or flu-like symptoms after the first infusion, compared with 11.7% of the placebo group

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Summary

Introduction

Anti-reabsorption medications are most widely used for treating osteoporosis. As a third generation of bisphosphonates (BPs), it outperforms the previous nitrogen-containing BPs in improving patients’ balance and quality of life by inhibiting bone reabsorption and increasing bone mineral density (BMD) [1] [2]. It is administrated via intravenous drip infusion once a year, which, brings good compliance with treatment. The patients who are afraid of any adverse reactions or have suffered from any side effects during the first administration may show poor compliance with the second dose and refuse the clinical application of zoledronic acid. This study aims to investigate whether sequential regimen, namely, traditional anti-reabsorption medications (alendronate sodium, calcitonin or raloxifene) followed by zoledronic acid could reduce or mitigate the acute side effects brought by zoledronic acid administration in postmenopausal patients with osteoporosis

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