Semi-mechanistic PK/PD Model of the Effect of Odanacatib, a Cathepsin K Inhibitor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women

Authors: Zajic S, Stone J, Jaworowicz DJ, Leung A, Duong LT, Passarell JA, Fiedler-Kelly J, Cohn D, Verbruggen N, Stoch A
Keywords: Odanacatib, PK/PD, PopPK, population pharmacokinetics
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Background

Odanacatib (MK-0822), a potent, orally-active inhibitor of cathepsin K, is under clinical development for treatment of postmenopausal osteoporosis. This poster describes base model development of a semi-mechanistic model of bone turnover to describe creatinine adjusted urinary aminoterminal crosslinked telopeptides of Type I collagen (uNTx), a bone resorption biomarker, and lumbar spine bone mineral density (LS-BMD) data from two Phase II dose-ranging studies during and after treatment with odanacatib.

By Stefan Zajic, Julie A. Stone, David Jaworowicz, Albert Leung, Le Thi Duong, Julie Passarell, Jill Fiedler-Kelly, Dosinda Cohn, Nadia Verbruggen, and Aubrey Stoch