Phase 2
N=402
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
Fracture Healing
Bottom Line
View on ClinicalTrials.gov: NCT00907296 ↗Enrolled (actual)
402
Serious AEs
8.6%
Results posted
May 2019
Primary outcome: Primary: Time to Radiographic Healing — 16.4; 18.6; 18.3; 18.2 weeks — p=0.3598
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Romosozumab (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Radiographic Healing |
16.4; 18.6; 18.3; 18.2; 17.8; 18.1 | 0.3598 |
| SECONDARY Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain |
5.77; 6.31; 5.67; 5.04; 4.28; 7.08 | — |
| SECONDARY Number of Participants With Unplanned Revision Surgeries |
8; 1; 3; 3; 1; 0 | — |
| SECONDARY Time to Clinical Healing |
18.4; 21.4; 18.3; 17.1; 20.8; 22.3 | 0.1713 |
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 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
Data sourced from ClinicalTrials.gov (NCT00907296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.