title: Effect of zoledronic acid on serum calcium in Paget's disease patients after educational strategies to improve calcium and vitamin D supplementation.
abstract: OBJECTIVE
  Bisphosphonates are the most effective therapeutic agents in patients with Paget's disease of bone. As a result of their inhibition of osteoclastic activity, hypocalcemia of variable frequency and severity following intravenous bisphosphonate therapy has been reported. The present study assessed the effect of physician and patient education on adequate supplementation of calcium and vitamin D to reduce the potential risk of developing hypocalcemia following infusion of 5 mg zoledronic acid.
  
  
  METHODS
  This was an open-label, multicenter, controlled registry trial in which patients with Paget's disease were treated with a single intravenous infusion of zoledronic acid. Physicians were provided with educational materials focusing on optimization of calcium and vitamin D supplementation following zoledronic infusion that they used to educate their patients. The primary safety variable was the percentage of patients with serum calcium level <2.07mmol/l 9-11 days after zoledronic acid infusion.
  
  
  RESULTS
  A total of 75 patients were evaluable in the post dose hypocalcemia safety analysis. Of these, only 1 patient had treatment-emergent hypocalcemia, with a serum calcium level of 1.92 mmol/l 4 days following therapy. Hypocalcemia-related symptoms were not reported in this patient and the serum calcium returned to normal range at 2.17 mmol/l within 1 week on oral calcium supplementation.
  
  
  CONCLUSIONS
  These results suggest that, with optimization of calcium and vitamin D supplementation by physician and patient education, hypocalcemia is an infrequent occurrence following zoledronic acid infusion.
authors: Division of Endocrinology, Roger Williams Medical Center, 825 Chalkstone Avenue, Providence, RI 02908, USA.
authors: Joseph R
authors: JR
authors: Tucci
authors: Michigan Bone and Mineral Clinic, Detroit, Michigan 48236, USA.
authors: Henry G
authors: HG
authors: Bone
authors: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors: Guoqin
authors: G
authors: Su
authors: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors: Monique
authors: M
authors: Tan
authors: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors: Zafer E
authors: ZE
authors: Ozturk
authors: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors: Paul
authors: P
authors: Aftring
keywords: Paget’s disease; bisphosphonates; hypocalcemia; zoledronic acid