title: Incidence of ocular side effects with intravenous zoledronate: secondary analysis of a randomized controlled trial.
abstract: CONCLUSIONS
  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%.
  
  
  BACKGROUND
  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.
authors.affiliation: Department of Ophthalmology, New Zealand National Eye Centre, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand, dipika.patel@auckland.ac.nz.
authors.forename: D V
authors.initials: DV
authors.lastname: Patel
authors.forename: M
authors.initials: M
authors.lastname: Bolland
authors.forename: Z
authors.initials: Z
authors.lastname: Nisa
authors.forename: F
authors.initials: F
authors.lastname: Al-Abuwsi
authors.forename: M
authors.initials: M
authors.lastname: Singh
authors.forename: A
authors.initials: A
authors.lastname: Horne
authors.forename: I R
authors.initials: IR
authors.lastname: Reid
authors.forename: C N J
authors.initials: CN
authors.lastname: McGhee
mesh_terms: D000208:Acute Disease; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000009:adverse effects*; D001851:Bone Diseases, Metabolic / Q000188:drug therapy*; D004164:Diphosphonates / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects*; D015994:Incidence; D007262:Infusions, Intravenous / Q000009:adverse effects; D008875:Middle Aged; D017698:Postmenopause; D011446:Prospective Studies; D015423:Scleritis / Q000139:chemically induced* / Q000453:epidemiology; D016896:Treatment Outcome; D014606:Uveitis, Anterior / Q000139:chemically induced* / Q000453:epidemiology; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid