20080394 Phase 2 study with AMG 785 in fractures of the Proximal Femur

• Research type

  Research Study

• Full title

  A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral Intertrochanteric Fracture of the Proximal Femur, Status Post Fixation with a Sliding Hip Screw or Intramedullary Nail

• IRAS ID

  41063

• Contact name

  Simon Donell

• Sponsor organisation

  Amgen Ltd

• Eudract number

  2009-015939-33

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Bone fractures are a common injury in the UK and although many of these heal without complications, for certain fracture types this is not always the case. The complications that can occur include nonunion (where the fracture does not heal), malunion (where the fracture doesn??t heal properly), additional unplanned surgery and infections. As a result of these complications, some patients don??t regain the full function of the fractured limb. Hip fractures are typically caused by low energy trauma (i.e. a fall from standing height or lower) and commonly occur in patients with osteoporosis. Due to an aging population, the worldwide incidence of hip fractures is expected to continue to grow over the coming decades. As a result of the temporary or permanent loss of independence that these patients experience, hip fractures are a high burden on healthcare and society. The purpose of this research study is to evaluate whether the investigational drug, AMG 785 can affect the healing time of fractures of the hip in adults. The study will look at the effect of AMG 785 on the function of the fractured leg, healing or general health complications, pain, general mobility, 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 assess how safe and well tolerated AMG 785 is in the patient??s body. Patients 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

  10/H0406/13

• Date of REC Opinion

  15 Feb 2010

• REC opinion

  Favourable Opinion