title: Zoledronate for Osteogenesis imperfecta: evaluation of safety profile in children.
abstract: BACKGROUND
  The advent of bisphosphonates (BPs) has revolutionised the outcome of Osteogenesis imperfecta (OI) in the last few years. There has always been a safety concern regarding zoledronate's use due to a paucity of studies. The current study is a retrospective evaluation of children with OI on the short- and long-term side effects of zoledronate and the frequency of fractures per year after the drug was introduced.
  
  
  METHODS
  A total of 26 children diagnosed with OI, with a median age of 84 (45-121) months were enrolled in the study. They received cyclical zoledronate for a median duration of 36 (11-61) months at quarterly intervals between January 2008 and December 2014. Safety evaluation involved assessment of its short- and long-term effects in addition to the frequency of fractures after its usage.
  
  
  RESULTS
  One (3%) neonate had symptomatic hypocalcemia 15 days after the infusion. Three children (11%) had acute phase reactions. None had long-term side effects, including osteonecrosis of the jaw, in our 7-year experience. OI of types III and IV (total of 22) had significant reductions in the number of fractures (p<0.05).
  
  
  CONCLUSIONS
  Further long-duration studies are necessary to evaluate the longterm safety of zoledronate.
authors.forename: Chanchal
authors.initials: C
authors.lastname: Kumar
authors.forename: Inusha
authors.initials: I
authors.lastname: Panigrahi
authors.forename: Abhishek
authors.initials: A
authors.lastname: Somasekhara Aradhya
authors.forename: Babu Lal
authors.initials: BL
authors.lastname: Meena
authors.forename: Niranjan
authors.initials: N
authors.lastname: Khandelwal
mesh_terms: D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004164:Diphosphonates / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D050723:Fractures, Bone / Q000517:prevention & control*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D007223:Infant; D008297:Male; D010013:Osteogenesis Imperfecta / Q000188:drug therapy*; D011379:Prognosis; D012189:Retrospective Studies; D012449:Safety; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid