title: Effect of zoledronic acid compared with raloxifene on bone turnover markers in postmenopausal women with low bone density.
abstract: OBJECTIVE
  The aim of this study was to assess the effects of zoledronic acid and raloxifene on bone turnover markers.
  
  
  METHODS
  This multicenter, randomized, double-blind study involved 110 postmenopausal women with low bone mineral density who received either a single intravenous infusion of zoledronic acid 5 mg or 6 months of daily oral raloxifene 60 mg. The primary efficacy variable was change from baseline in the bone resorption marker urine N-telopeptide of type I collagen. The secondary efficacy variable was change from baseline in the bone formation marker serum bone-specific alkaline phosphatase. Analysis time points were at 2, 4, and 6 (primary) months.
  
  
  RESULTS
  At 6 months, zoledronic acid produced a significantly greater reduction than did raloxifene in urine N-telopeptide of type I collagen (P < 0.001). Zoledronic acid also yielded significantly greater decreases in urine N-telopeptide of type I collagen at 2 and 4 months and in serum bone-specific alkaline phosphatase at all time points (P < 0.001 vs raloxifene for all comparisons). Both treatments were well tolerated. More adverse events occurred in the zoledronic acid group; these were primarily transient postdose symptoms that occurred within the first 3 days after the infusion.
  
  
  CONCLUSIONS
  Zoledronic acid demonstrated significantly greater decreases in bone turnover markers than did raloxifene in postmenopausal women with low bone mass.
authors.affiliation: Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ 08901, USA. bachmaga@umdnj.edu
authors.forename: Gloria
authors.initials: G
authors.lastname: Bachmann
authors.forename: Audrey
authors.initials: A
authors.lastname: Kriegman
authors.forename: Joana
authors.initials: J
authors.lastname: Gonçalves
authors.forename: Farid
authors.initials: F
authors.lastname: Kianifard
authors.forename: Michelle
authors.initials: M
authors.lastname: Warren
authors.forename: James A
authors.initials: JA
authors.lastname: Simon
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000652:urine; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000494:pharmacology; D016723:Bone Remodeling / Q000187:drug effects*; D024042:Collagen Type I / Q000652:urine; D004164:Diphosphonates / Q000008:administration & dosage* / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000494:pharmacology; D007262:Infusions, Intravenous; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000652:urine; D010455:Peptides / Q000652:urine; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage* / Q000494:pharmacology; D014481:United States; D000077211:Zoledronic Acid
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D004164:Diphosphonates; D007093:Imidazoles; D010455:Peptides; D020845:Selective Estrogen Receptor Modulators; C052929:collagen type I trimeric cross-linked peptide; D000077211:Zoledronic Acid