title: Zoledronic Acid Treatment After Acute Spinal Cord Injury: Results of a Randomized, Placebo-Controlled Pilot Trial.
abstract: To determine the effect of intravenous zoledronic acid 5 mg on the extent and course of bone loss after spinal cord injury (SCI).
  
  
  
  Double-blind, randomized, placebo-controlled parallel-group trial.
  
  
  
  Acute in-patient, tertiary-care rehabilitation hospital.
  
  
  
  Convenience sample of 17 in-patients with SCI <12 weeks before randomization; American Spinal Injury Association Impairment scale A, B, or C and medically stable. Twelve patients were evaluated at the primary endpoint at 6 months.
  
  
  
  Patients meeting study criteria were randomly assigned to zoledronic acid 5 mg or matching placebo. Dual x-ray absorptiometry scan and serum for bone markers (type 1 procollagen amino-terminal propeptide, bone-specific alkaline phosphatase, collagen type 1 cross-linked C-telopeptide) were obtained at baseline and after 3 months, 6 months, and the every 6 months for up to 2 years.
  
  
  
  The primary endpoint was change in bone mineral density (BMD) at the total hip after 6 months; secondary endpoints were changes in BMD at other skeletal sites and changes in levels of serum bone markers.
  
  
  
  The group treated with zoledronic acid had a smaller decrease in BMD at 6 months at the total hip than the placebo group (right: -2.2 ± 3.4% versus -8.6 ± 3.5%, respectively, P = .03; left: -3.7 ± 1.0% versus -12.3 ± 6.9%, P = .03). Differences in BMD at the femoral neck were similar (right: -5.1 ± 6.5% versus -20.0 ± 6.4%, P = .01; left: -1.1 ± 3.5% versus -11.1 ± 7.4%, P = .02) with larger bone loss and smaller between group differences at the knee. Zoledronic acid resulted in a decrease in serum levels of both formation and resorption markers.
  
  
  
  Zoledronic acid is effective at mitigating bone loss after SCI. Duration of efficacy and activity at different skeletal sites may differ from that observed in able-bodied individuals and needs further study.
authors.affiliation: Northwestern University Feinberg School of Medicine, 303 E. Chicago Avenue, Chicago, IL 60611(∗). Electronic address: tjs@northwestern.edu.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Schnitzer
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL; Rehabilitation Institute of Chicago, Chicago, IL(†).
authors.forename: Ki
authors.initials: K
authors.lastname: Kim
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL(‡).
authors.forename: Julia
authors.initials: J
authors.lastname: Marks
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL(§).
authors.forename: Renita
authors.initials: R
authors.lastname: Yeasted
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL(¶).
authors.forename: Narina
authors.initials: N
authors.lastname: Simonian
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL; Rehabilitation Institute of Chicago, Chicago, IL(#).
authors.forename: David
authors.initials: D
authors.lastname: Chen
mesh_terms: D015519:Bone Density; D004164:Diphosphonates; D004311:Double-Blind Method; D006801:Humans; D007093:Imidazoles; D010865:Pilot Projects; D013119:Spinal Cord Injuries / Q000188:drug therapy*; D000077211:Zoledronic Acid
chemical_list: D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid