title: Efficacy and safety of oral recombinant calcitonin tablets in postmenopausal women with low bone mass and increased fracture risk: a randomized, placebo-controlled trial.
abstract: The effect of an investigational oral calcitonin tablet upon bone mineral density (BMD) of the spine was investigated in postmenopausal women with low bone mass and at increased risk of fracture. Compared to placebo, calcitonin tablets increased lumbar spine BMD. This agent may provide an additional choice for patients.
  
  
  BACKGROUND
  An investigational oral salmon calcitonin preparation was previously shown to increase lumbar spine BMD in postmenopausal women with osteoporosis. Our objective was to evaluate the use of this agent in postmenopausal women with low bone mass and at increased fracture risk but not meeting BMD criteria for osteoporosis.
  
  
  METHODS
  Treatment-naïve women were randomized to receive oral recombinant salmon calcitonin tablets or placebo once daily for 1 year. Dual-energy X-ray absorptiometry was performed at baseline and at study weeks 28 and 54. CTx-1, a bone resorption marker, was obtained at the same time points. Subjects returned periodically for tolerability assessment and adverse event (AE) recording.
  
  
  RESULTS
  One hundred twenty-nine women in the USA were randomized, 86 to calcitonin and 43 to placebo. Calcitonin recipients experienced a significant increase from baseline in lumbar spine BMD; the difference compared with placebo was significant. Dosing at bedtime or with dinner was equally effective. CTx-1 was suppressed in calcitonin recipients but not in placebo subjects. Gastrointestinal AEs were common, but the overall safety profile was comparable between groups.
  
  
  CONCLUSIONS
  Oral calcitonin may provide a useful therapeutic alternative for some women with low bone mass.
authors.affiliation: University of Wisconsin Osteoporosis Clinical Center and Research Program, Madison, WI, USA, nbinkley@wisc.edu.
authors.forename: N
authors.initials: N
authors.lastname: Binkley
authors.forename: H
authors.initials: H
authors.lastname: Bone
authors.forename: J P
authors.initials: JP
authors.lastname: Gilligan
authors.forename: D S
authors.initials: DS
authors.lastname: Krause
mesh_terms: D015502:Absorptiometry, Photon / Q000379:methods; D000284:Administration, Oral; D000368:Aged; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002116:Calcitonin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D024042:Collagen Type I / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005272:Femur Neck / Q000503:physiopathology; D006621:Hip Joint / Q000503:physiopathology; D006801:Humans; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D058866:Osteoporotic Fractures / Q000209:etiology / Q000517:prevention & control*; D010455:Peptides / Q000097:blood; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; C028815:salmon calcitonin; D002116:Calcitonin