Osteoporosis International

, Volume 23, Issue 2, pp 503–512

Treatment with acetaminophen/paracetamol or ibuprofen alleviates post-dose symptoms related to intravenous infusion with zoledronic acid 5 mg

  • J. D. Wark
  • W. Bensen
  • C. Recknor
  • O. Ryabitseva
  • J. ChiodoIII
  • P. Mesenbrink
  • T. J. de Villiers
Original Article

DOI: 10.1007/s00198-011-1563-8

Cite this article as:
Wark, J.D., Bensen, W., Recknor, C. et al. Osteoporos Int (2012) 23: 503. doi:10.1007/s00198-011-1563-8

Abstract

Summary

Patients treated with intravenous zoledronic acid 5 mg for osteoporosis may experience post-dose influenza-like symptoms. Oral acetaminophen/paracetamol or ibuprofen administered 4 h post-infusion reduced the proportion of patients with increased oral temperature and worsening post-infusion symptom scores vs. placebo, thus providing an effective strategy for the treatment of such symptoms.

Introduction

Once-yearly intravenous zoledronic acid 5 mg is a safe and effective treatment for postmenopausal osteoporosis. This study assessed whether transient influenza-like post-dose symptoms associated with intravenous infusion of zoledronic acid can be reduced by post-dose administration of acetaminophen/paracetamol or ibuprofen.

Methods

In an international, multicenter, randomized, double-blind, double-dummy parallel-group study, bisphosphonate-naïve postmenopausal women with osteopenia (n = 481) were randomized to receive zoledronic acid 5 mg + acetaminophen/paracetamol (n = 135), ibuprofen (n = 137) or placebo (n = 137), or placebo + placebo (n = 72). Acetaminophen/paracetamol and ibuprofen were administered every 6 h for 3 days beginning 4 h post-infusion.

Results

The proportion of patients with increased oral temperature (≥1°C above 37.5°C) and with worsening post-infusion symptom scores over 3 days was significantly lower in patients receiving ibuprofen (36.8% and 48.5%) or acetaminophen/paracetamol (37.3% and 46.3%) vs. those receiving placebo (63.5% and 75.9%, respectively; all p < 0.0001) compared with background rates of 11.1% and 16.7%, respectively, in the absence of any active treatment. Overall incidence of adverse events was comparable for patients receiving acetaminophen/paracetamol or ibuprofen.

Conclusion

Oral acetaminophen/paracetamol or ibuprofen effectively managed the transient influenza-like symptoms associated with zoledronic acid 5 mg.

Keywords

AcetaminophenIbuprofenParacetamolZoledronic acid

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2011

Authors and Affiliations

  • J. D. Wark
    • 1
  • W. Bensen
    • 2
  • C. Recknor
    • 3
  • O. Ryabitseva
    • 4
  • J. ChiodoIII
    • 5
  • P. Mesenbrink
    • 6
  • T. J. de Villiers
    • 7
  1. 1.University of Melbourne Department of Medicine and Bone & Mineral ServiceThe Royal Melbourne HospitalMelbourneAustralia
  2. 2.St. Joseph’s Hospital, McMaster UniversityHamiltonCanada
  3. 3.United Osteoporosis CentersGainesvilleUSA
  4. 4.Regional Hospital No. 1YekaterinburgRussian Federation
  5. 5.Otsuka America Pharmaceuticals Inc.PrincetonUSA
  6. 6.Novartis Pharmaceuticals CorporationEast HanoverUSA
  7. 7.Panorama MediClinic and Stellenbosch UniversityCape TownSouth Africa