Journal Article

Incidence of ocular side effects with intravenous zoledronate: secondary analysis of a randomized controlled trial

Patel, D. V., Nisa, Z., Horne, A., Singh, M., McGhee, C. N. J., Bolland, M., Reid, I. R., Al-Abuwsi, F.

2015

Overview

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.

• Publisher: Springer London,Springer Nature B.V
• Subject: Acute Disease / Bone Density - drug effects / Bone Density Conservation Agents - adverse effects / Bone Diseases, Metabolic - drug therapy / Diphosphonates - adverse effects / Double-Blind Method / Drug therapy / Endocrinology / Eyes & eyesight / Female / Humans / Imidazoles - adverse effects / Incidence / Infusions, Intravenous - adverse effects / Intravenous therapy / Medicine / Medicine & Public Health / Middle Aged / Original Article / Orthopedics / Osteoporosis / Postmenopause / Prospective Studies / Rheumatology / Scleritis - chemically induced / Scleritis - epidemiology / Side effects / Treatment Outcome / Uveitis, Anterior - chemically induced / Uveitis, Anterior - epidemiology