title: Sustained-release sodium fluoride in the treatment of the elderly with established osteoporosis.
abstract: BACKGROUND
  We ascertained the safety and efficacy of fluoride in augmenting spinal bone mass and reducing spinal fractures in older women with established osteoporosis. We compared a combination of sustained-release sodium fluoride, calcium citrate, and cholecalciferol (SR-NaF group) with calcium and cholecalciferol alone (control group).
  
  
  METHODS
  Eighty-five ambulatory women aged 65 years or older with 1 or more nontraumatic vertebral compression fractures were enrolled in a 42-month randomized, double-blind, placebo-controlled trial. Primary outcome measures were vertebral fracture rate, bone mass, and safety.
  
  
  RESULTS
  The vertebral fracture rate determined by means of computer assistance in the SR-NaF group was significantly lower than that in the control group (relative risk [RR], 0.32; 95% confidence interval [CI], 0.14-0.73; P =.007). Results of visual adjudicated inspection also confirmed a significant reduction in fracture rate (RR, 0.40; 95% CI, 0.17-0.95; P =.04). Bone mineral density in L2 through L4 increased significantly from baseline in the SR-NaF group by 5.4% (95% CI, 2.7%-8.2%; P<.001), and by 3.2% in the control group (95% CI, 0.8%-5.6%; P =.01). The between-group differences in bone mineral density were not significant. The femoral neck and total hip bone mineral density remained stable in the SR-NaF group and was not significantly different from that of the control group. There were no significant differences in adverse effects between groups.
  
  
  CONCLUSIONS
  The SR-NaF group significantly decreased the risk for vertebral fractures and increased spinal bone mass without reducing bone mass at the femoral neck and total hip.
authors.affiliation: Geriatrics Section, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-8889, USA. Craig.Rubin@UTSouthwestern.edu
authors.forename: C D
authors.initials: CD
authors.lastname: Rubin
authors.forename: C Y
authors.initials: CY
authors.lastname: Pak
authors.forename: B
authors.initials: B
authors.lastname: Adams-Huet
authors.forename: H K
authors.initials: HK
authors.lastname: Genant
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.forename: D S
authors.initials: DS
authors.lastname: Rao
mesh_terms: D000368:Aged; D000553:Ambulatory Care; D001772:Blood Cell Count; D015519:Bone Density / Q000187:drug effects; D002118:Calcium / Q000652:urine; D019355:Calcium Citrate / Q000008:administration & dosage / Q000627:therapeutic use; D002762:Cholecalciferol / Q000008:administration & dosage / Q000627:therapeutic use; D003094:Collagen / Q000652:urine; D024042:Collagen Type I; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D009780:Occult Blood; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy*; D010455:Peptides / Q000652:urine; D011859:Radiography; D017701:Reticulocyte Count; D012969:Sodium Fluoride / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use*; D016103:Spinal Fractures / Q000097:blood / Q000000981:diagnostic imaging / Q000517:prevention & control*
chemical_list: D024042:Collagen Type I; D003692:Delayed-Action Preparations; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D002762:Cholecalciferol; D012969:Sodium Fluoride; D003094:Collagen; D019355:Calcium Citrate; D002118:Calcium