Overview

Efficacy of Zoledronic Acid in Enhancement of Early Stability of Cementless Primary Hip Prosthesis

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind and placebo-controlled study to evaluate the efficacy of zoledronic acid on the biologic incorporation of cementless hip prosthesis in postmenopausal female patients.The study population consists of postmenopausal female patients scheduled for total hip replacement because of degenerative hip osteoarthritis. The patients will receive either a single dose of 5 mg zoledronic acid or placebo intravenously after surgery before hospital discharge. The patients will be followed-up for 1 year. Zoledronic acid therapy has been shown to promote bone ingrowth into porous implants in pre-clinical models. The investigators hypothesis is that zoledronic acid, given as a single intravenous infusion after hip replacement surgery, enhances bone ingrowth into porous surface of cementless hip prostheses. As a primary outcome, the therapy is expected to reduce periprosthetic bone loss measured by DXA. Enhancement of bone ingrowth is expected to increase primary stability of the hip prosthesis and this effect can be detected with high-precision three-dimensional RSA imaging modality and in a faster functional recovery of the patients.
Phase:
Phase 4
Details
Lead Sponsor:
Turku University Hospital
Collaborators:
Academy of Finland
Novartis
Stryker Nordic
Treatments:
Diphosphonates
Zoledronic Acid