title: Intravenous zoledronate improves bone density in adults with cystic fibrosis (CF).
abstract: OBJECTIVE
  Reduced bone mineral density (BMD) and increased rates of atraumatic fracture are observed in cystic fibrosis (CF) patients, causing increasing morbidity as this population ages. The study aimed to assess the safety, tolerability and effect on BMD of intravenous zoledronate in adults with CF and osteopaenia.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled clinical trial.
  
  
  METHODS
  Adult CF outpatient clinics at two hospitals.
  
  
  METHODS
  Twenty-two non-transplanted CF patients aged > or = 18 years with a bone densitometry T-score of < -1.5 at one of three sites (lumbar spine, femoral neck, distal forearm) were studied. Participants were randomized to receive either 2 mg zoledronate i.v. (n = 10) or normal saline (placebo, n = 12) every 3 months for 2 years (8 infusions). All participants received calcium and vitamin D supplements twice daily.
  
  
  METHODS
  Percentage change in areal BMD from baseline.
  
  
  RESULTS
  Lumbar spine BMD increased from baseline more with zoledronate than placebo at 6 months (5.35 +/- 0.76 vs. 1.19 +/- 1.20%, P = 0.012), 12 months (6.6 +/- 1.5 vs. 0.35 +/- 1.55%, P = 0.011) and 24 months (6.14 +/- 1.86 vs. 0.44 +/- 0.10, P = 0.021). Femoral neck BMD increased more after zoledronate than placebo at 6 months (3.2 +/- 1.6 vs.-1.43 +/- 0.43%, P = 0.019), 12 months (4.12 +/- 1.8 vs.-1.59 +/- 1.4%, P = 0.024) and 24 months (4.23 +/- 1.3 vs.-2.5 +/- 1.41%, P = 0.0028). Forearm BMD did not change. Zoledronate was associated with flu-like and musculoskeletal side effects, particularly after the first infusion. There were no fractures in either group.
  
  
  CONCLUSIONS
  Intravenous zoledronate was significantly more effective than placebo for increasing BMD in adults with CF and osteopaenia, but side effects limited its tolerability.
authors.affiliation: Endocrinology Department, Royal Adelaide Hospital, North Terrace, Adelaide, Australia.
authors.forename: Ian
authors.initials: I
authors.lastname: Chapman
authors.forename: Hugh
authors.initials: H
authors.lastname: Greville
authors.forename: Peter R
authors.initials: PR
authors.lastname: Ebeling
authors.forename: Susannah J
authors.initials: SJ
authors.lastname: King
authors.forename: Tom
authors.initials: T
authors.lastname: Kotsimbos
authors.forename: Patricia
authors.initials: P
authors.lastname: Nugent
authors.forename: Rosie
authors.initials: R
authors.lastname: Player
authors.forename: Duncan J
authors.initials: DJ
authors.lastname: Topliss
authors.forename: Janet
authors.initials: J
authors.lastname: Warner
authors.forename: John W
authors.initials: JW
authors.lastname: Wilson
mesh_terms: D000328:Adult; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D003550:Cystic Fibrosis / Q000150:complications* / Q000188:drug therapy; D004164:Diphosphonates / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D010024:Osteoporosis / Q000188:drug therapy* / Q000209:etiology; D010919:Placebos; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D010919:Placebos; D000077211:Zoledronic Acid