ICCBH2019 Oral Communications (1) (27 abstracts)
Comparison of zoledronate and pamidronate in children with skeletal disorders: Short term safety experience from a single institution
Laura Tosi 1 , Andrea Estrada 1 , Marianne Floor 1 , Mirini Kim 1 , Lindsay Weigley 1 , Christina Dollar 1 , Austin Gillies 1 , Mary Scott Roberts 2 , Rachel Gafni 2 & Alison Boyce 2
1Children’s National Health System, Washington, District of Columbia, USA; 2National Institute of Health, Bethesda, Maryland, USA.
Objectives: Bisphosphonates are frequently used in children with skeletal disorders, however optimal dosing and regimens are unknown. Early treatment focused on pamidronate (PAM), a second-generation formulation, however use of zoledronate (ZOL), a more potent third-generation bisphosphonate, has recently increased due to shorter and less frequent infusions. The objective of this study is to compare short-term safety of ZOL and PAM in a pediatric population.
Methods: We performed a ten year retrospective chart review including demographics, indications for treatment, and bisphosphonate used. Adverse events (AEs) for 7 days post-infusion were categorized: i) Acute phase reactions (APR): fever, bone pain, myalgia, decreased oral intake, and/or fatigue; ii) nausea/vomiting; iii) hypocalcemia (serum calcium <8.5 mg/dl); iv) seizures; v) respiratory distress; vi) anaphylaxis; vii) emergency department evaluations and hospital admissions.
Results: 119 patients (median age 8.6y, range 0.1–23.4) received 782 infusions (46 ZOL, 736 PAM) between June 2007 and August 2017. The most common diagnoses were osteogenesis imperfecta (31%), cerebral palsy (22%), and muscular dystrophy (12%). AEs were more common after ZOL than PAM: 50% vs 23.1% for initial infusions, P=0.03; and 18.8% vs 4.5% for subsequent infusions, P=0.0004. APRs occurred after 6/46 total ZOL infusions (13.0%) vs 28/736 total PAM infusions (3.8%) (P=0.003). Nausea/vomiting occurred after 4/46 ZOL (8.7%) vs 20/736 PAM infusions (2.7%) (P=0.02). Hypocalcemia occurred after 5/46 ZOL (10.8%) vs 4/736 PAM infusions (0.5%) (P<0.0001), and was managed with oral calcium and calcitriol. An increase over baseline seizure activity was reported after 2/46 ZOL (4.3%) vs 1/736 PAM infusions (P<0.0001). Respiratory distress occurred after 0/46 ZOL and 2/736 PAM infusions (P=0.72) There were no cases of anaphylaxis. Emergency department evaluations and/or admissions occurred after 2/46 ZOL (4.3%) and 4/736 PAM infusions (0.5%) (P=0.04).
Conclusion: ZOL treatment is associated with a higher incidence of AEs compared to PAM, consistent with its greater potency. While AEs following both ZOL and PAM are common, they are generally mild and treatable. Additional research regarding long-term safety, efficacy, and cost are needed to determine if ZOL’s convenience justifies its routine use over PAM.
Disclosure: The authors declared no competing interests.
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