title: The effect of teriparatide compared with risedronate on reduction of back pain in postmenopausal women with osteoporotic vertebral fractures.
abstract: The effect of teriparatide and risedronate on back pain was tested, and there was no difference in the proportion of patients experiencing a reduction in back pain between groups after 6 or 18 months. Patients receiving teriparatide had greater increases in bone mineral density and had fewer vertebral fractures.
  
  
  BACKGROUND
  This study aimed to understand the effect of teriparatide in reducing back pain in patients with prevalent back pain and vertebral fracture compared to risedronate.
  
  
  METHODS
  In an 18-month randomized, double-blind, double-dummy trial, we investigated the effects of teriparatide (20 μg/day) vs. risedronate (35 mg/week) in postmenopausal women with back pain likely due to vertebral fracture. The primary objective was to compare the proportion of subjects reporting ≥30% reduction in worst back pain severity from baseline to 6 months as assessed by a numeric rating scale in each treatment group. Pre-specified secondary and exploratory outcomes included assessments of average and worst back pain at additional time points, disability and quality of life, bone mineral density, incidence of fractures, and safety.
  
  
  RESULTS
  At 6 months, 59% of teriparatide and 57% of risedronate patients reported ≥30% reduction in worst back pain and there were no differences between groups in the proportion of patients experiencing reduction in worst or average back pain at any time point, disability, or quality of life. There was a greater increase from baseline in bone mineral density at the lumbar spine (p = 0.001) and femoral neck (p = 0.02) with teriparatide compared to risedronate and a lower incidence of vertebral fractures at 18 months (4% teriparatide and 9% risedronate; p = 0.01). Vertebral fractures were less severe (p = 0.04) in the teriparatide group. There was no difference in the overall incidence of adverse events.
  
  
  CONCLUSIONS
  Although there were no differences in back pain-related endpoints, patients receiving teriparatide had greater skeletal benefit than those receiving risedronate.
authors.affiliation: Department of Endocrinology, Osteoporosis, and Reproductive Medicine, Philipps-University of Marburg, Marburg, Germany. hadji@med.uni-marburg.de
authors.forename: P
authors.initials: P
authors.lastname: Hadji
authors.forename: J R
authors.initials: JR
authors.lastname: Zanchetta
authors.forename: L
authors.initials: L
authors.lastname: Russo
authors.forename: C P
authors.initials: CP
authors.lastname: Recknor
authors.forename: K G
authors.initials: KG
authors.lastname: Saag
authors.forename: F E
authors.initials: FE
authors.lastname: McKiernan
authors.forename: S L
authors.initials: SL
authors.lastname: Silverman
authors.forename: J
authors.initials: J
authors.lastname: Alam
authors.forename: R T
authors.initials: RT
authors.lastname: Burge
authors.forename: J H
authors.initials: JH
authors.lastname: Krege
authors.forename: M C
authors.initials: MC
authors.lastname: Lakshmanan
authors.forename: D N
authors.initials: DN
authors.lastname: Masica
authors.forename: B H
authors.initials: BH
authors.lastname: Mitlak
authors.forename: J L
authors.initials: JL
authors.lastname: Stock
mesh_terms: D000368:Aged; D001416:Back Pain / Q000188:drug therapy* / Q000209:etiology; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D012968:Etidronic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D005272:Femur Neck / Q000187:drug effects; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy*; D058866:Osteoporotic Fractures / Q000150:complications / Q000188:drug therapy*; D010147:Pain Measurement; D011788:Quality of Life; D000068296:Risedronic Acid; D016103:Spinal Fractures / Q000150:complications / Q000188:drug therapy*; D019379:Teriparatide / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide; D000068296:Risedronic Acid; D012968:Etidronic Acid