Abstract
Summary
This prospective study showed that the incidence of acute anterior uveitis, confirmed by ophthalmic examination, in patients receiving intravenous zoledronate infusions as part of a randomized controlled trial for fracture prevention is 1.1 %.
Introduction
We prospectively investigated the incidence of ocular side effects after a single intravenous zoledronate infusion.
Methods
In a secondary analysis of a double-blind, placebo-controlled trial in which early post-menopausal women (N = 1054) with normal bone density or osteopenia were randomized to infusion of zoledronate 5 mg (N = 703) or placebo (N = 351), we analyzed significant adverse ocular events occurring within 3 months.
Results
Fourteen participants reported ocular symptoms after the infusion. All were examined by an ophthalmologist and eight were diagnosed with acute anterior uveitis (AAU) and one with sectoral episcleritis. The incidence of AAU and episcleritis was 1.1 % (95 % CI 0.5–2.1) and 0.1 % (95 % CI 0.0–0.7), respectively, in the zoledronate group and 0 % for both conditions in the placebo group (95 % CI 0.0–0.8). The mean time from infusion to symptom onset for AAU was 3 days (range 2–4). Three cases were bilateral. AAU was mild-moderate in seven participants and severe in one. All affected eyes were treated with topical cyclopentolate 1 % (to break, or minimize, posterior synechiae), and intensive, potent, topical corticosteroids with a tapering regime based on treatment response. The mean duration of topical corticosteroid was 26 ± 10 days (range 17–44). The mean, best corrected visual acuity was 20/20 (range 20/20–20/40) at presentation, which remained unchanged after AAU resolution. None of the participants lost vision, and no long-term sequelae were reported at last follow-up (range 3–13 months post-infusion).
Conclusions
Prescribers should inform patients about the possibility of ocular side effects with zoledronate infusions and refer promptly to an ophthalmologist if symptoms develop.
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Acknowledgments
The authors would like to acknowledge Greg Gamble, Statistician, Department of Medicine, University of Auckland, for his statistical advice and guidance on this paper. This study is registered with the Australian Clinical Trials Registry ACTRN12612000270819.
Financial support
This study was funded by the Health Research Council of New Zealand. The funding organization had no role in the design or conduct of this research.
Conflicts of interest
Dr. Reid has received research support and/or acted as a consultant for Novartis, Amgen and Merck. Dipika V. Patel, Mark Bolland, Zaynah Nisa, Fadiya Al-Abuwsi, Manisha Singh, Anne Horne and Charles NJ McGhee declare that they have no conflict of interest.
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Patel, D.V., Bolland, M., Nisa, Z. et al. Incidence of ocular side effects with intravenous zoledronate: secondary analysis of a randomized controlled trial. Osteoporos Int 26, 499–503 (2015). https://doi.org/10.1007/s00198-014-2872-5
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DOI: https://doi.org/10.1007/s00198-014-2872-5