Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
NCT ID: NCT00907296
Last Updated: 2022-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
402 participants
INTERVENTIONAL
2009-09-02
2013-05-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
Placebo
Administered by subcutaneous injection
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.
Romosozumab
Administered by subcutaneous injection
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.
Romosozumab
Administered by subcutaneous injection
Romosozumab 70 mg: 4 Doses
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
Romosozumab
Administered by subcutaneous injection
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.
Romosozumab
Administered by subcutaneous injection
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.
Romosozumab
Administered by subcutaneous injection
Romosozumab 140 mg: 4 Doses
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
Romosozumab
Administered by subcutaneous injection
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.
Romosozumab
Administered by subcutaneous injection
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.
Romosozumab
Administered by subcutaneous injection
Romosozumab 210 mg: 4 Doses
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
Romosozumab
Administered by subcutaneous injection
Interventions
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Romosozumab
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Orange, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Jacksonville, Florida, United States
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Indianapolis, Indiana, United States
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Detroit, Michigan, United States
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St Louis, Missouri, United States
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Brooklyn, New York, United States
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Rochester, New York, United States
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Altoona, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Sandy City, Utah, United States
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Geelong, Victoria, Australia
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Parkville, Victoria, Australia
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Blagoevgrad, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Red Deer, Alberta, Canada
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Ajax, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Ã…rhus C, , Denmark
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Hvidovre, , Denmark
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København NV, , Denmark
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Tallinn, , Estonia
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Tartu, , Estonia
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Lille, , France
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Marseille, , France
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Nantes, , France
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Paris, , France
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Aachen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Mannheim, , Germany
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Münster, , Germany
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Athens, , Greece
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Athens, , Greece
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Larissa, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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New Territories, , Hong Kong
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Budapest, , Hungary
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Miskolc, , Hungary
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Nyíregyháza, , Hungary
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Szeged, , Hungary
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Pune, Maharashtra, India
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Jaipur, Rajasthan, India
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Madurai, Tamil Nadu, India
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Gandhinagar, , India
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Mangalore, , India
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Nashik, , India
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Pisa, , Italy
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Roma (RM), , Italy
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Verona, , Italy
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Liepāja, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Valmiera, , Latvia
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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Monterrey, Nuevo León, Mexico
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Christchurch, , New Zealand
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Tauranga, , New Zealand
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Kongsvinger, , Norway
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Bialystok, , Poland
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Bytom, , Poland
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Kraków, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
Research Site
Timișoara, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Bratislava, , Slovakia
Research Site
Nitra, , Slovakia
Research Site
Piešťany, , Slovakia
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Leeds, , United Kingdom
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London, , United Kingdom
Research Site
Newcastle, , United Kingdom
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Norwich, , United Kingdom
Research Site
Oxford, , United Kingdom
Research Site
Stanmore, , United Kingdom
Countries
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References
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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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2008-008392-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20062017
Identifier Type: -
Identifier Source: org_study_id
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