A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of AMG 785 in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation with an Intramedullary Nail Study to Assess Healing of Repaired Tibias with Sclerostin Antibody (STARTT)
5715 - CTO
Surgery - Orthopaedic
Principal Investigator: Stuart T Guthrie, MD
Primary - To investigate the effect of AMG 785 compared to placebo on time to radiographic healing of fresh tibial diaphyseal fractures.
Secondary - To evaluate the effect of AMG 785 compared to placebo on:
- Physical functioning as measured by the Short Form (36) Survey
- Incidence of unplanned revision surgery
- Time to clinical healing as determined by the ability to bear weight on the fracture limb and the absence of pain at the fracture site
Minimal Requirements: please contact our office for a full list of criteria.
- Skeletally mature adults, at least 18 - 85 years of age at randomization, with radiographically closed growth plates
- Fresh unilateral closed or Gustillo type I or type II open tibial diaphyseal fracture as the primary injury (fracture line must not extend into the ankle or knee joint)
- Meet inclusion criteria (in detail) for open and closed fractures
Clinical Trials Office