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Modeling of Serum C‐Telopeptide Levels with Daily and Monthly Oral Ibandronate in Humans
Author(s) -
ZAIDI MONE,
EPSTEIN SOLOMON,
FRIEND KEITH
Publication year - 2006
Publication title -
annals of the new york academy of sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.712
H-Index - 248
eISSN - 1749-6632
pISSN - 0077-8923
DOI - 10.1196/annals.1346.058
Subject(s) - bone resorption , medicine , pharmacodynamics , n terminal telopeptide , bone remodeling , pharmacokinetics , resorption , endocrinology , chemistry , osteocalcin , alkaline phosphatase , biochemistry , enzyme
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.