Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
STARTT
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
2 other identifiers
interventional
402
23 countries
103
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Typical duration for phase_2
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2009
CompletedFirst Posted
Study publicly available on registry
May 22, 2009
CompletedStudy Start
First participant enrolled
September 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2013
CompletedResults Posted
Study results publicly available
May 1, 2019
CompletedSeptember 22, 2022
September 1, 2022
2.5 years
May 21, 2009
April 10, 2019
September 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Radiographic Healing
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.
52 weeks
Secondary Outcomes (3)
Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain
Week 8 and weeks 12, 16, 20, 24, 36, and 52
Number of Participants With Unplanned Revision Surgeries
52 weeks
Time to Clinical Healing
52 weeks
Study Arms (10)
Placebo
PLACEBO COMPARATORParticipants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
Romosozumab 70 mg: 2 Doses
EXPERIMENTALParticipants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Romosozumab 70 mg: 3 Doses
EXPERIMENTALParticipants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Romosozumab 70 mg: 4 Doses
EXPERIMENTALParticipants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
Romosozumab 140 mg: 2 Doses
EXPERIMENTALParticipants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Romosozumab 140 mg: 3 Doses
EXPERIMENTALParticipants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Romosozumab 140 mg: 4 Doses
EXPERIMENTALParticipants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
Romosozumab 210 mg: 2 Doses
EXPERIMENTALParticipants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Romosozumab 210 mg: 3 Doses
EXPERIMENTALParticipants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Romosozumab 210 mg: 4 Doses
EXPERIMENTALParticipants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
Interventions
Administered by subcutaneous injection
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- UCB Pharmacollaborator
Study Sites (103)
Research Site
Birmingham, Alabama, 35294, United States
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Orange, California, 92868, United States
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Aurora, Colorado, 80012, United States
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Denver, Colorado, 80204, United States
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Jacksonville, Florida, 32209, United States
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Indianapolis, Indiana, 46202, United States
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Detroit, Michigan, 48202, United States
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St Louis, Missouri, 63110, United States
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Brooklyn, New York, 11220, United States
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Rochester, New York, 14642, United States
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Altoona, Pennsylvania, 16602, United States
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Philadelphia, Pennsylvania, 19104, United States
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Columbia, South Carolina, 29203, United States
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Sandy City, Utah, 84070, United States
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Geelong, Victoria, 3220, Australia
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Parkville, Victoria, 3050, Australia
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Blagoevgrad, 2700, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7000, Bulgaria
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Sofia, 1527, Bulgaria
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Red Deer, Alberta, T4N 6V7, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Thunder Bay, Ontario, P7B 7C7, Canada
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Toronto, Ontario, M5C 1R6, Canada
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Waterloo, Ontario, N2J 1C4, Canada
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Windsor, Ontario, N9A 1E1, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Ã…rhus C, 8000, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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Tallinn, 11312, Estonia
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Tartu, 50410, Estonia
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Lille, 59000, France
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Marseille, 13009, France
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Nantes, 44035, France
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Paris, 75571, France
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Aachen, 52074, Germany
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Hamburg, 20246, Germany
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Hanover, 30625, Germany
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Mannheim, 68165, Germany
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Münster, 48149, Germany
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Athens, 12462, Greece
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Athens, 14561, Greece
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Larissa, 41110, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 56429, Greece
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Budapest, 1081, Hungary
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Miskolc, 3526, Hungary
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Nyíregyháza, 4400, Hungary
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Szeged, 6725, Hungary
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Bangalore, Karnataka, 560 034, India
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Bangalore, Karnataka, 560 054, India
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Mangalore, Karnataka, 575 002, India
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Pune, Maharashtra, 411 005, India
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Jaipur, Rajasthan, 302 022, India
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Madurai, Tamil Nadu, 625 020, India
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Gandhinagar, 382 428, India
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Mangalore, 575 001, India
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Nashik, 422 009, India
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Florence, 50139, Italy
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Milan, 20122, Italy
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Milan, 20142, Italy
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Pisa, 56126, Italy
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Roma (RM), 00133, Italy
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Verona, 37126, Italy
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Liepāja, 3400, Latvia
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Riga, 1004, Latvia
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Riga, 1005, Latvia
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Valmiera, 4201, Latvia
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Kaunas, 44320, Lithuania
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Vilnius, 04130, Lithuania
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Monterrey, Nuevo León, 64040, Mexico
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Christchurch, 8022, New Zealand
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Tauranga, 3143, New Zealand
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Kongsvinger, 2226, Norway
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Bialystok, 15-276, Poland
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Bytom, 41-902, Poland
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Kraków, 31-826, Poland
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Krakow, 30-901, Poland
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Lublin, 20-718, Poland
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Bucharest, 014461, Romania
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Bucharest, 050098, Romania
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Timișoara, 300736, Romania
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Moscow, 115280, Russia
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Moscow, 117292, Russia
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Moscow, 119049, Russia
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Moscow, 127299, Russia
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Moscow, 129327, Russia
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Saint Petersburg, 196247, Russia
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Yaroslavl, 150003, Russia
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Bratislava, 833 05, Slovakia
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Nitra, 950 01, Slovakia
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Piešťany, 921 01, Slovakia
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Leeds, LS1 3EX, United Kingdom
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London, E1 1BB, United Kingdom
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Newcastle, NE1 4LP, United Kingdom
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Norwich, NR4 7UY, United Kingdom
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Oxford, OX3 9DU, United Kingdom
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Stanmore, HA7 4LP, United Kingdom
Related Publications (1)
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.
PMID: 32358413BACKGROUND
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2009
First Posted
May 22, 2009
Study Start
September 2, 2009
Primary Completion
March 6, 2012
Study Completion
May 10, 2013
Last Updated
September 22, 2022
Results First Posted
May 1, 2019
Record last verified: 2022-09