Modeling of serum C-telopeptide levels with daily and monthly oral ibandronate in humans.
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.
Zaidi
Mone
M
Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1055, New York, NY 10029, USA. mone.zaidi@msnyuhealth.edu
Epstein
Solomon
S
Friend
Keith
K
D015415:Biomarkers / Q000097:blood; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D024042:Collagen Type I / Q000097:blood*; D004164:Diphosphonates / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D008991:Monitoring, Physiologic; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000188:drug therapy*; D010455:Peptides / Q000097:blood*
D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D004164:Diphosphonates; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D000077557:Ibandronic Acid