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:

  1. Physical functioning as measured by the Short Form (36) Survey
  2. Incidence of unplanned revision surgery
  3. 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.

  1. Skeletally mature adults, at least 18 - 85 years of age at randomization, with radiographically closed growth plates
  2. 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)
  3. Meet inclusion criteria (in detail) for open and closed fractures
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