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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00907296
Registration number
NCT00907296
Ethics application status
Date submitted
21/05/2009
Date registered
22/05/2009
Date last updated
22/09/2022
Titles & IDs
Public title
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
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Scientific title
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
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Secondary ID [1]
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2008-008392-34
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Secondary ID [2]
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20062017
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Universal Trial Number (UTN)
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Trial acronym
STARTT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fracture Healing
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Condition category
Condition code
Injuries and Accidents
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0
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Fractures
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Musculoskeletal
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Romosozumab
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
Experimental: Romosozumab 70 mg: 2 Doses - Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Experimental: Romosozumab 70 mg: 3 Doses - Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Experimental: Romosozumab 70 mg: 4 Doses - Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
Experimental: Romosozumab 140 mg: 2 Doses - Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Experimental: Romosozumab 140 mg: 3 Doses - Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Experimental: Romosozumab 140 mg: 4 Doses - Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
Experimental: Romosozumab 210 mg: 2 Doses - Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Experimental: Romosozumab 210 mg: 3 Doses - Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Experimental: Romosozumab 210 mg: 4 Doses - Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
Other interventions: Romosozumab
Administered by subcutaneous injection
Treatment: Drugs: Placebo
Administered by subcutaneous injection
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Radiographic Healing
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Assessment method [1]
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Time to radiographic healing was defined as the time from intramedullary (IM) nailing to the first occurrence of bridging of 3 out of 4 cortices. Radiographic fracture healing was determined by a panel of independent reviewers (orthopedic/trauma surgeons and radiologists) blinded to treatment.
The cumulative incidence function (CIF) method was used to estimate the median time to radiographic healing and the confidence intervals. Unplanned revision surgery to promote healing was considered a competing risk in CIF estimate.
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Timepoint [1]
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52 weeks
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Secondary outcome [1]
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Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain
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Assessment method [1]
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The Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2, is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical functioning domain includes 10 questions that assess limitations in physical activities because of health problems.
Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. The range of SF-36 physical functioning is 14.94 - 57.03. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement in physical functioning.
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Timepoint [1]
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Week 8 and weeks 12, 16, 20, 24, 36, and 52
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Secondary outcome [2]
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Number of Participants With Unplanned Revision Surgeries
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Assessment method [2]
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Timepoint [2]
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52 weeks
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Secondary outcome [3]
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Time to Clinical Healing
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Assessment method [3]
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Time to clinical healing was defined as the time from the IM nailing surgery date to the first date that both the score for ability to bear weight on the fractured limb and the score for absence of pain at the fracture site were equal to 6.
The score for the ability to bear weight on the fractured limb was based on the ability to stand on affected leg without assistive device and the ability to walk without assistive device. The score ranges from 0 (unable to bear full body weight on the fractured limb) to 6 (able to bear full body weight on the fractured limb). Absence of pain at the fracture site was based on the absence of pain at the fracture site when applying direct pressure to the fracture site and applying a stress to the fracture site. The score ranges from 0 (pain without palpation at fracture site) to 6 (total absence of pain at fracture site).
Time to clinical healing was estimated using CIF; unplanned revision surgery was considered a competing risk in CIF estimate.
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Timepoint [3]
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52 weeks
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Eligibility
Key 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
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Minimum age
18
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/09/2009
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
10/05/2013
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Sample size
Target
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Accrual to date
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Final
402
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Research Site - Geelong
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Research Site - Parkville
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3220 - Geelong
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3050 - Parkville
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Stanmore
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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UCB Pharma
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Ethics approval
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00907296
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Trial related presentations / publications
Bhandari M, Schemitsch EH, Karachalios T, Sancheti P, Poolman RW, Caminis J, Daizadeh N, Dent-Acosta RE, Egbuna O, Chines A, Miclau T. Romosozumab in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture: A Randomized Phase-2 Study. J Bone Joint Surg Am. 2020 Aug 19;102(16):1416-1426. doi: 10.2106/JBJS.19.01008.
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00907296
Download to PDF