Effect of implantation of Augment(®) Bone Graft on serum concentrations of platelet-derived growth factors: a pharmacokinetic study

Clin Drug Investig. 2013 Feb;33(2):143-9. doi: 10.1007/s40261-013-0053-5.

Abstract

Background: Augment(®) Bone Graft is a bone graft substitute intended to be used as an alternative to autologous bone graft in the fusion of hindfoot and ankle joints. Augment(®) Bone Graft is a combination device comprised of beta-tricalcium phosphate (β-TCP) and recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB).

Objective: This human pharmacokinetic study was undertaken to assess the effect of Augment(®) Bone Graft implantation on the serum concentration of platelet-derived growth factors (PDGFs).

Methods: Under the terms of a Research Ethics Board-approved protocol, Augment(®) Bone Graft was implanted in patients (n = 7) undergoing hindfoot and ankle arthrodesis procedures requiring graft material. The control cohort of the study (n = 4) received autologous bone graft. The serum concentrations of PDGF isoforms AA, AB and BB in blood samples, obtained prior to and at ten time points (up to 7 days) after surgery, were measured using enzyme-linked immunosorbent assays (ELISA).

Results: The serum concentration of PDGF-BB did not vary significantly from baseline (median of the combined cohorts 3.89 ng/mL) throughout the course of the study. The serum concentrations of PDGF-AA, PDGF-AB and total PDGF did not deviate from their baseline values (medians of the combined cohorts were 2.87, 14.95 and 20.19 ng/mL for PDGF-AA, PDGF-AB and total PDGF, respectively) except for the last time point in which they were increased (medians for the combined cohorts were 4.71, 20.42 and 30.29 ng/mL for PDGF-AA, PDGF-AB and total PDGF, respectively). There were no differences between the two treatment groups with regard to changes in the serum concentrations of PDGF. None of the samples tested contained anti-PDGF-BB antibodies.

Conclusion: Analysis of the data demonstrated that the serum concentrations of all three PDGF isoforms analysed were unaffected by implantation of Augment(®) Bone Graft.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Ankle Joint
  • Arthrodesis / methods
  • Becaplermin
  • Biocompatible Materials / administration & dosage
  • Biocompatible Materials / pharmacology*
  • Calcium Phosphates / administration & dosage
  • Calcium Phosphates / pharmacology*
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Humans
  • Male
  • Middle Aged
  • Platelet-Derived Growth Factor / metabolism*
  • Proto-Oncogene Proteins c-sis / blood*
  • Time Factors

Substances

  • Biocompatible Materials
  • Calcium Phosphates
  • Platelet-Derived Growth Factor
  • Proto-Oncogene Proteins c-sis
  • beta-tricalcium phosphate
  • platelet-derived growth factor A
  • platelet-derived growth factor AB
  • Becaplermin