Modeling of serum C-telopeptide levels with daily and monthly oral ibandronate in humans

Ann N Y Acad Sci. 2006 Apr;1068:560-3. doi: 10.1196/annals.1346.058.

Abstract

A previously validated kinetic-pharmacodynamic model was applied to changes in a marker of bone resorption (serum C-telopeptide cross-links of type I collagen [sCTX]) using data from a large-scale clinical trial of ibandronate (Monthly Oral iBandronate In LadiEs [MOBILE]). The model showed rapid and significant suppression of sCTX compared to baseline with daily and monthly ibandronate, and gradual recovery of sCTX levels between monthly doses. This modeled, post-dose oscillatory pattern of sCTX paralleled significant increases in BMD and was associated with an acceptable safety profile for patients in MOBILE, suggesting that the between-dose recovery of sCTX does not negatively affect the efficacy of once-monthly ibandronate.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Biomarkers / blood
  • Bone Density Conservation Agents / therapeutic use*
  • Collagen Type I / blood*
  • Diphosphonates / therapeutic use*
  • Female
  • Humans
  • Ibandronic Acid
  • Monitoring, Physiologic
  • Osteoporosis, Postmenopausal / blood
  • Osteoporosis, Postmenopausal / drug therapy*
  • Peptides / blood*

Substances

  • Biomarkers
  • Bone Density Conservation Agents
  • Collagen Type I
  • Diphosphonates
  • Peptides
  • collagen type I trimeric cross-linked peptide
  • Ibandronic Acid