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Study Complete
Sponsor ID
20062017

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

Sponsor ID
20062017
Clinicaltrials.gov ID
NCT00907296
EUCTIS ID
N/A
EudraCT ID
2008-008392-34
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Study Details

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).

Additional Study Details

Phase
Phase 2
Product
AMG 785
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
402
Additional Study Details

Protocol Summary

Primary Outcome Measures

Time to radiographic healing for the AMG 785 and placebo groups

Timeframe: 24 weeks

Secondary Outcome Measures

Physical functioning as measured by change from baseline in the SF-36 PF

Timeframe: 52 weeks

Subject incidence of revision surgery

Timeframe: 52 weeks

Time to clinical healing as determined by the ability to bear weight on the fractured limb and the absence of pain at the fracture site

Timeframe: 52 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Sandy, UT, United States, 84070
Status
Completed
Location
Research Site
Brooklyn, NY, United States, 11220
Status
Recruiting
Location
Research Site
Rochester, NY, United States, 14642
Status
Recruiting
Location
Research Site
Orange, CA, United States, 92868
Status
Recruiting
Location
Research Site
Detroit, MI, United States, 48202
Status
Completed
Location
Research Site
Columbia, SC, United States, 29203
Status
Completed
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Study Info
Age
18 - 85 Years
Condition
  • Fracture
    • Sex
    All
    Trial Dates
    Sep 2009 - Mar 2012
    Inclusion and Exclusion Criteria
    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