PURPOSE: To investigate the incidence of significant adverse ocular side effects after intravenous zoledronate infusion for osteopenia. DESIGN: Data analysis of a large, prospective, randomized, double-blind, placebo-controlled clinical trial. PARTICIPANTS: Postmenopausal women (n = 2001) with osteopenia randomized toplacebo or zoledronate infusion. INTERVENTION: Intravenous infusion of zoledronate 5 mg or placebo. MAIN OUTCOME MEASURES: Adverse ocular events. RESULTS:Eight participants (mean age, 70.4 ± 5.3 years) with uniocular or bilateral painful red eye were diagnosed with acute anterior uveitis (AAU) after examination by an ophthalmologist. All cases of AAU were from the zoledronate arm of the study, where the incidence was 0.8%. The mean time from infusion to onset of symptoms was 3 ± 2 days (range, 1-7 days). The AAU affected 3 right eyes and 4 left eyes and was bilateral in 1 patient (12.5%). Six of the participants exhibited mild to moderate AAU and 2 had severe AAU. Posterior synechiae occurred in 3 cases. The mean best-corrected visual acuity was reduced slightly at 20/30 (range, 20/20-20/60) at presentation, but improved to 20/25 (range, 20/20-20/30) upon resolution of AAU. All cases were treated with intensive, potent, topical corticosteroids: prednisolone acetate 1% eye drops with or without dexamethasone 0.1% eye ointment, with a tapering regimen based on the response to treatment. All eyes also were treated with topical cyclopentolate 1% to break or minimize the development of posterior synechiae. The mean duration of topical corticosteroid treatment was 45 ± 28 days (median, 47 days; range, 12-94 days). No long-term sequelae were reported (range, 8-23 months after infusion). CONCLUSIONS: This is the largest reported cohort of cases of ophthalmologist-confirmed AAU occurring after intravenous infusion of zoledronate (5 mg). Eight of 1001 subjects receivingzoledronate (0.8%) exhibited mild to severe AAU within 7 days of treatment. The severity of ocular inflammation identified ranged from mild to severe AAU and thus required several weeks of treatment. Physicians and patients should be aware of the risk of ocular inflammatory side effects of bisphosphonate infusions and the need for referral to an ophthalmologist if symptoms develop.
RCT Entities:
PURPOSE: To investigate the incidence of significant adverse ocular side effects after intravenous zoledronate infusion for osteopenia. DESIGN: Data analysis of a large, prospective, randomized, double-blind, placebo-controlled clinical trial. PARTICIPANTS: Postmenopausal women (n = 2001) with osteopenia randomized to placebo or zoledronate infusion. INTERVENTION: Intravenous infusion of zoledronate 5 mg or placebo. MAIN OUTCOME MEASURES: Adverse ocular events. RESULTS: Eight participants (mean age, 70.4 ± 5.3 years) with uniocular or bilateral painful red eye were diagnosed with acute anterior uveitis (AAU) after examination by an ophthalmologist. All cases of AAU were from the zoledronate arm of the study, where the incidence was 0.8%. The mean time from infusion to onset of symptoms was 3 ± 2 days (range, 1-7 days). The AAU affected 3 right eyes and 4 left eyes and was bilateral in 1 patient (12.5%). Six of the participants exhibited mild to moderate AAU and 2 had severe AAU. Posterior synechiae occurred in 3 cases. The mean best-corrected visual acuity was reduced slightly at 20/30 (range, 20/20-20/60) at presentation, but improved to 20/25 (range, 20/20-20/30) upon resolution of AAU. All cases were treated with intensive, potent, topical corticosteroids: prednisolone acetate 1% eye drops with or without dexamethasone 0.1% eye ointment, with a tapering regimen based on the response to treatment. All eyes also were treated with topical cyclopentolate 1% to break or minimize the development of posterior synechiae. The mean duration of topical corticosteroid treatment was 45 ± 28 days (median, 47 days; range, 12-94 days). No long-term sequelae were reported (range, 8-23 months after infusion). CONCLUSIONS: This is the largest reported cohort of cases of ophthalmologist-confirmed AAU occurring after intravenous infusion of zoledronate (5 mg). Eight of 1001 subjects receiving zoledronate (0.8%) exhibited mild to severe AAU within 7 days of treatment. The severity of ocular inflammation identified ranged from mild to severe AAU and thus required several weeks of treatment. Physicians and patients should be aware of the risk of ocular inflammatory side effects of bisphosphonate infusions and the need for referral to an ophthalmologist if symptoms develop.
Authors: D V Patel; M Bolland; Z Nisa; F Al-Abuwsi; M Singh; A Horne; I R Reid; C N J McGhee Journal: Osteoporos Int Date: 2014-09-04 Impact factor: 4.507