Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing

Completed · Phase 2 · Has a placebo group

Conditions studied: Fracture Healing

In brief

The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

Key facts

Study ID

NCT00907296

Run by

Amgen

People needed

402

Starts

2009-09-02

Expected to finish

2013-05-10

Last updated by the study team

2022-09-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates
• Fresh unilateral closed or Gustilo type I or type II open tibial fracture
• Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing

You may not qualify if…

• Major polytrauma or significant axial trauma
• Associated lower extremity fracture that will delay subject's ability to bear weight beyond the normal time expected for a tibial shaft fracture
• Use of bone grafts at the time of fracture fixation
• Pathological fracture or metabolic or bone disease
• History of symptomatic spinal stenosis or facial nerve paralysis
• Malignancy within the last 5 years
• Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia
• Use of agents affecting bone metabolism
• Subject refuses to use appropriate methods of contraception

Where it is running

• Research Site — Orange, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Detroit, Michigan, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Altoona, Pennsylvania, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Columbia, South Carolina, United States
• Research Site — Sandy City, Utah, United States
• Research Site — Geelong, Victoria, Australia
• Research Site — Parkville, Victoria, Australia
• Research Site — Blagoevgrad, Bulgaria
• Research Site — Pleven, Bulgaria
• Research Site — Plovdiv, Bulgaria
• Research Site — Rousse, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Red Deer, Alberta, Canada
• Research Site — Ajax, Ontario, Canada
• Research Site — Thunder Bay, Ontario, Canada
• Research Site — Toronto, Ontario, Canada
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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