A Phase 2 study with AMG 785 in fresh tibial diaphyseal fractures

• Research type

  Research Study

• Full title

  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

• IRAS ID

  25148

• Contact name

  Simon Donell

• Eudract number

  2008-008392-34

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Every year, many people fracture bones, for example, in the United States it is over 6 million adults each year. Many broken bones heal without complications; however, this is not always the case for certain types of fractures. The complications that may occur are nonunion (the fracture does not heal at all), malunion (the fracture does not heal properly), additional, unplanned surgery and infections. As a consequence, patients may not regain the full function of the fractured limb and may be forced to miss work for longer than expected. The purpose of this study is to evaluate whether the investigational drug AMG 785 can affect the healing time of fractures of the tibia (a bone in the lower leg) in adults. This research study will also look at the effect of AMG 785 on the function of the lower leg, pain at the fracture site, the quality of life of patients while the fracture heals and the ability to return to work. The results of this study will help Amgen Inc. to determine the best possible doses of AMG 785 to be used in future studies. They will also be used to asses how safe and well tolerated AMG 785 is in the patient's body. Patient's will also be asked to provide blood samples. These samples will be studied to look for special markers that can be used to tailor the use of AMG 785 in treating bone diseases and bone fractures and/or to study bone diseases and fracture healing.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/88

• Date of REC Opinion

  30 Sep 2009

• REC opinion

  Further Information Favourable Opinion