PMID- 26308295
OWN - NLM
STAT- MEDLINE
DCOM- 20160217
LR  - 20181202
IS  - 1945-7197 (Electronic)
IS  - 0021-972X (Print)
IS  - 0021-972X (Linking)
VI  - 100
IP  - 11
DP  - 2015 Nov
TI  - Short-Term Safety of Zoledronic Acid in Young Patients With Bone Disorders: An 
      Extensive Institutional Experience.
PG  - 4163-71
LID - 10.1210/jc.2015-2680 [doi]
AB  - CONTEXT: Zoledronic acid (ZA) is increasingly used in young patients with bone 
      disorders. However, data related to the safety of ZA administration in this 
      population are limited. OBJECTIVE: The study aimed to characterize the short-term 
      safety profile of ZA and identify risk factors for ZA-related adverse events 
      (AEs) in young patients. DESIGN, SETTING, AND PARTICIPANTS: This was a 
      retrospective chart review of inpatients and outpatients less than 21 years old 
      who received at least one ZA infusion between July 2010 and January 2014 at The 
      Children's Hospital of Philadelphia. RESULTS: Eighty-one patients (56% male; 
      median age, 12 y; age at first infusion, 0.5 to 20 y) with diverse skeletal 
      disorders received a total of 204 infusions. The most common indications were 
      osteoporosis (33% of cohort) and osteogenesis imperfecta (27.2%). The median ZA 
      dose was 0.025 mg/kg (interquartile range, 0.025-0.05); the median dosing 
      interval was 6 months (range, 1 to 25.6 mo). AEs were mild and more common after 
      the first ZA infusion in patients with no previous bisphosphonate exposure: 
      hypophosphatemia (25.2% of infusions), acute phase reactions (19.1%), and 
      hypocalcemia (16.4%). Symptomatic hypocalcemia requiring iv calcium occurred 
      after two infusions. ZA dose was significantly associated with hypophosphatemia, 
      but not other AEs. Hypocalcemia was more common in patients with high bone 
      turnover as assessed by preinfusion alkaline phosphatase levels. AEs were not 
      associated with diagnosis, baseline serum calcium, or calcium/calcitriol 
      supplementation. CONCLUSION: Acute AEs related to ZA infusion in youths are 
      common, occur principally after the first ZA infusion in bisphosphonate-naive 
      patients, and are typically mild and easily managed. Future prospective studies 
      are needed to determine the potential long-term risks, as well as benefits, of ZA 
      therapy in the pediatric population.
FAU - George, Sobenna
AU  - George S
AD  - Division of General Pediatrics (S.G.), Division of Endocrinology and Diabetes 
      (D.R.W., M.A.L.), Division of Genetics (P.K.), and Department of Pharmacy (K.H., 
      H.M.M.), The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 
      19104; Department of Pediatrics (P.K., M.A.L.), University of Pennsylvania 
      Perelman School of Medicine, Philadelphia, Pennsylvania 19104; and University of 
      Rochester School of Medicine and Dentistry (D.R.W.), Rochester, New York 14642.
FAU - Weber, David R
AU  - Weber DR
AD  - Division of General Pediatrics (S.G.), Division of Endocrinology and Diabetes 
      (D.R.W., M.A.L.), Division of Genetics (P.K.), and Department of Pharmacy (K.H., 
      H.M.M.), The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 
      19104; Department of Pediatrics (P.K., M.A.L.), University of Pennsylvania 
      Perelman School of Medicine, Philadelphia, Pennsylvania 19104; and University of 
      Rochester School of Medicine and Dentistry (D.R.W.), Rochester, New York 14642.
FAU - Kaplan, Paige
AU  - Kaplan P
AD  - Division of General Pediatrics (S.G.), Division of Endocrinology and Diabetes 
      (D.R.W., M.A.L.), Division of Genetics (P.K.), and Department of Pharmacy (K.H., 
      H.M.M.), The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 
      19104; Department of Pediatrics (P.K., M.A.L.), University of Pennsylvania 
      Perelman School of Medicine, Philadelphia, Pennsylvania 19104; and University of 
      Rochester School of Medicine and Dentistry (D.R.W.), Rochester, New York 14642.
FAU - Hummel, Kelly
AU  - Hummel K
AD  - Division of General Pediatrics (S.G.), Division of Endocrinology and Diabetes 
      (D.R.W., M.A.L.), Division of Genetics (P.K.), and Department of Pharmacy (K.H., 
      H.M.M.), The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 
      19104; Department of Pediatrics (P.K., M.A.L.), University of Pennsylvania 
      Perelman School of Medicine, Philadelphia, Pennsylvania 19104; and University of 
      Rochester School of Medicine and Dentistry (D.R.W.), Rochester, New York 14642.
FAU - Monk, Heather M
AU  - Monk HM
AD  - Division of General Pediatrics (S.G.), Division of Endocrinology and Diabetes 
      (D.R.W., M.A.L.), Division of Genetics (P.K.), and Department of Pharmacy (K.H., 
      H.M.M.), The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 
      19104; Department of Pediatrics (P.K., M.A.L.), University of Pennsylvania 
      Perelman School of Medicine, Philadelphia, Pennsylvania 19104; and University of 
      Rochester School of Medicine and Dentistry (D.R.W.), Rochester, New York 14642.
FAU - Levine, Michael A
AU  - Levine MA
AD  - Division of General Pediatrics (S.G.), Division of Endocrinology and Diabetes 
      (D.R.W., M.A.L.), Division of Genetics (P.K.), and Department of Pharmacy (K.H., 
      H.M.M.), The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 
      19104; Department of Pediatrics (P.K., M.A.L.), University of Pennsylvania 
      Perelman School of Medicine, Philadelphia, Pennsylvania 19104; and University of 
      Rochester School of Medicine and Dentistry (D.R.W.), Rochester, New York 14642.
LA  - eng
GR  - K12 HD068373/HD/NICHD NIH HHS/United States
GR  - T32 DK063688/DK/NIDDK NIH HHS/United States
GR  - K12HD068373/HD/NICHD NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20150826
PL  - United States
TA  - J Clin Endocrinol Metab
JT  - The Journal of clinical endocrinology and metabolism
JID - 0375362
RN  - 0 (Bone Density Conservation Agents)
RN  - 0 (Diphosphonates)
RN  - 0 (Imidazoles)
RN  - 6XC1PAD3KF (Zoledronic Acid)
RN  - EC 3.1.3.1 (Alkaline Phosphatase)
RN  - FXC9231JVH (Calcitriol)
RN  - SY7Q814VUP (Calcium)
SB  - IM
MH  - Acute-Phase Reaction/chemically induced
MH  - Adolescent
MH  - Alkaline Phosphatase/metabolism
MH  - Bone Density Conservation Agents/administration & dosage/*adverse 
      effects/therapeutic use
MH  - Bone Diseases/*complications/drug therapy
MH  - Calcitriol/therapeutic use
MH  - Calcium/therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Diphosphonates/administration & dosage/*adverse effects/therapeutic use
MH  - Female
MH  - Humans
MH  - Hypercalcemia/drug therapy
MH  - Hypocalcemia/drug therapy
MH  - Hypophosphatemia/blood/chemically induced
MH  - Imidazoles/administration & dosage/*adverse effects/therapeutic use
MH  - Infant
MH  - Male
MH  - Osteogenesis Imperfecta/drug therapy
MH  - Osteoporosis/drug therapy
MH  - Prospective Studies
MH  - Retrospective Studies
MH  - Risk Factors
MH  - Young Adult
MH  - Zoledronic Acid
PMC - PMC4702447
EDAT- 2015/08/27 06:00
MHDA- 2016/02/18 06:00
PMCR- 2016/11/01
CRDT- 2015/08/27 06:00
PHST- 2015/08/27 06:00 [entrez]
PHST- 2015/08/27 06:00 [pubmed]
PHST- 2016/02/18 06:00 [medline]
PHST- 2016/11/01 00:00 [pmc-release]
AID - 15-2680 [pii]
AID - 10.1210/jc.2015-2680 [doi]
PST - ppublish
SO  - J Clin Endocrinol Metab. 2015 Nov;100(11):4163-71. doi: 10.1210/jc.2015-2680. 
      Epub 2015 Aug 26.