Loading clinical trials...

COMPLETEDPHASE2

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

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

NCT00907296•Amgen

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (103)

Research Site

Birmingham, Alabama, United States

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

Key Dates

Start Date

September 2, 2009

Primary Completion Date

March 6, 2012

Completion Date

May 10, 2013

Last Updated

September 22, 2022

Enrollment

402

ACTUAL participants

Conditions

Fracture Healing

Interventions

Romosozumab

BIOLOGICAL

Placebo

DRUG

Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture

NCT06658379

Fracture Non UnionFracture Healing+10 more

View study

NOT_YET_RECRUITING

Midterm Follow up of Pediatric Pelvic Fracture Management at Assiut University Hospital

NCT06591585

Fracture Healing

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture

Midterm Follow up of Pediatric Pelvic Fracture Management at Assiut University Hospital

Local Remodelling of Bone Fracture Healing

A mRUS Validation Study for Nail-treated Fractures of Long Bones and a TUS Exploratory Study for Nail and Plate-treated Fractures of Long Bones