Clinical trial NCT00907296: Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fracture Healing
Keywords: Fracture Healing
Tibial Diaphyseal Fracture
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: UCB Pharma
First posted: 2009-05-22
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Time to Radiographic Healing
timeFrame: 52 weeks
Secondary outcomes:
measure: Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain
timeFrame: Week 8 and weeks 12, 16, 20, 24, 36, and 52
measure: Number of Participants With Unplanned Revision Surgeries
timeFrame: 52 weeks
measure: Time to Clinical Healing
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Orange
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Altoona
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Sandy
country: United States
facility: Research Site
state: Utah
city: Geelong
country: Australia
facility: Research Site
state: Victoria
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Red Deer
country: Canada
facility: Research Site
state: Alberta
city: Ajax
country: Canada
facility: Research Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Hvidovre
country: Denmark
facility: Research Site
city: KÃ¸benhavn NV
country: Denmark
facility: Research Site
city: Ã…rhus C
country: Denmark
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Paris Cedex 12
country: France
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Muenster
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: New Territories
country: Hong Kong
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mangalore
country: India
facility: Research Site
state: Karnataka
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Gandhinagar
country: India
facility: Research Site
city: Mangalore
country: India
facility: Research Site
city: Nashik
country: India
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Roma (RM)
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Liepaja
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Valmiera
country: Latvia
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo LeÃ³n
city: Christchurch
country: New Zealand
facility: Research Site
city: Tauranga
country: New Zealand
facility: Research Site
city: Kongsvinger
country: Norway
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: KrakÃ³w
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Piestany
country: Slovakia
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Stanmore
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.