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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2008-008392-34
Secondary ID [2] 0 0
20062017
Universal Trial Number (UTN)
Trial acronym
STARTT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fracture Healing 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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.


Treatment: Other: Romosozumab
Administered by subcutaneous injection

Treatment: Drugs: Placebo
Administered by subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Radiographic Healing
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain
Timepoint [1] 0 0
Week 8 and weeks 12, 16, 20, 24, 36, and 52
Secondary outcome [2] 0 0
Number of Participants With Unplanned Revision Surgeries
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Time to Clinical Healing
Timepoint [3] 0 0
52 weeks

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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/05/2013
Sample size
Target
Accrual to date
Final
402
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Geelong
Recruitment hospital [2] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Michigan
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Missouri
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New York
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Pennsylvania
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South Carolina
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United States of America
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Utah
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Bulgaria
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Blagoevgrad
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Hvidovre
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Denmark
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København NV
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Denmark
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Ã…rhus C
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Lille
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France
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Marseille
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France
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Nantes Cedex 1
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France
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Paris Cedex 12
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Germany
State/province [29] 0 0
Aachen
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Germany
State/province [30] 0 0
Hamburg
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Germany
State/province [31] 0 0
Hannover
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Germany
State/province [32] 0 0
Mannheim
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Germany
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Muenster
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Greece
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Athens
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Greece
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Larissa
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Greece
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Patra
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Greece
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Thessaloniki
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Hong Kong
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Hong Kong
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Hong Kong
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New Territories
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Hungary
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Budapest
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Hungary
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Miskolc
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Hungary
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Nyiregyhaza
Country [43] 0 0
Hungary
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Szeged
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India
State/province [44] 0 0
Karnataka
Country [45] 0 0
India
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Maharashtra
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India
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Rajasthan
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India
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Tamil Nadu
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India
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Gandhinagar
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India
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Mangalore
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India
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Nashik
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Italy
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Firenze
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Italy
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Milano
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Italy
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Pisa
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Italy
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Roma (RM)
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Italy
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Verona
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Latvia
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Liepaja
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Latvia
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Riga
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Latvia
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Valmiera
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Mexico
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Nuevo León
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New Zealand
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Christchurch
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New Zealand
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Tauranga
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Norway
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Kongsvinger
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Poland
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Bialystok
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Poland
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Bytom
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Poland
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Krakow
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Poland
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Kraków
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Poland
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Lublin
Country [70] 0 0
Romania
State/province [70] 0 0
Bucharest
Country [71] 0 0
Romania
State/province [71] 0 0
Bucuresti
Country [72] 0 0
Romania
State/province [72] 0 0
Timisoara
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Moscow
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Saint Petersburg
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Russian Federation
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Yaroslavl
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Slovakia
State/province [76] 0 0
Bratislava
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Slovakia
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Nitra
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Slovakia
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Piestany
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United Kingdom
State/province [79] 0 0
Leeds
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United Kingdom
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London
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United Kingdom
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Newcastle
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United Kingdom
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Norwich
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United Kingdom
State/province [83] 0 0
Oxford
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Stanmore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
UCB Pharma
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT00907296
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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00907296