Back to resultsStudy of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing (STARTT)
Primary Purpose
Fracture Healing
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Romosozumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fracture Healing focused on measuring Fracture Healing, Tibial Diaphyseal Fracture
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
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
Romosozumab 70 mg: 2 Doses
Romosozumab 70 mg: 3 Doses
Romosozumab 70 mg: 4 Doses
Romosozumab 140 mg: 2 Doses
Romosozumab 140 mg: 3 Doses
Romosozumab 140 mg: 4 Doses
Romosozumab 210 mg: 2 Doses
Romosozumab 210 mg: 3 Doses
Romosozumab 210 mg: 4 Doses
Arm Description
Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain
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.
Number of Participants With Unplanned Revision Surgeries
Time to Clinical Healing
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.
Full Information
NCT ID
NCT00907296
First Posted
May 21, 2009
Last Updated
September 9, 2022
Sponsor
Amgen
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00907296
Brief Title
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
Acronym
STARTT
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2009 (Actual)
Primary Completion Date
March 6, 2012 (Actual)
Study Completion Date
May 10, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
Collaborators
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Healing
Keywords
Fracture Healing, Tibial Diaphyseal Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.
Arm Title
Romosozumab 70 mg: 2 Doses
Arm Type
Experimental
Arm Description
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Arm Title
Romosozumab 70 mg: 3 Doses
Arm Type
Experimental
Arm Description
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Arm Title
Romosozumab 70 mg: 4 Doses
Arm Type
Experimental
Arm Description
Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.
Arm Title
Romosozumab 140 mg: 2 Doses
Arm Type
Experimental
Arm Description
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Arm Title
Romosozumab 140 mg: 3 Doses
Arm Type
Experimental
Arm Description
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Arm Title
Romosozumab 140 mg: 4 Doses
Arm Type
Experimental
Arm Description
Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.
Arm Title
Romosozumab 210 mg: 2 Doses
Arm Type
Experimental
Arm Description
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.
Arm Title
Romosozumab 210 mg: 3 Doses
Arm Type
Experimental
Arm Description
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.
Arm Title
Romosozumab 210 mg: 4 Doses
Arm Type
Experimental
Arm Description
Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
Intervention Type
Biological
Intervention Name(s)
Romosozumab
Other Intervention Name(s)
AMG 785, Evenity
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Time to Radiographic Healing
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain
Description
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.
Time Frame
Week 8 and weeks 12, 16, 20, 24, 36, and 52
Title
Number of Participants With Unplanned Revision Surgeries
Time Frame
52 weeks
Title
Time to Clinical Healing
Description
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.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Research Site
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
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Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
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Research Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Research Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Research Site
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Research Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
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Australia
Facility Name
Research Site
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
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City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
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City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
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City
Sofia
ZIP/Postal Code
1527
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Bulgaria
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City
Red Deer
State/Province
Alberta
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T4N 6V7
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Canada
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City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Facility Name
Research Site
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 7C7
Country
Canada
Facility Name
Research Site
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Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada
Facility Name
Research Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1E1
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Research Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Research Site
City
København NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Research Site
City
Ã…rhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
50410
Country
Estonia
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Research Site
City
Nantes Cedex 1
ZIP/Postal Code
44035
Country
France
Facility Name
Research Site
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Research Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Mannheim
ZIP/Postal Code
68165
Country
Germany
Facility Name
Research Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
14561
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Research Site
City
Patra
ZIP/Postal Code
26500
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
New Territories
Country
Hong Kong
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1081
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 054
Country
India
Facility Name
Research Site
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575 002
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 005
Country
India
Facility Name
Research Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302 022
Country
India
Facility Name
Research Site
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 020
Country
India
Facility Name
Research Site
City
Gandhinagar
ZIP/Postal Code
382 428
Country
India
Facility Name
Research Site
City
Mangalore
ZIP/Postal Code
575 001
Country
India
Facility Name
Research Site
City
Nashik
ZIP/Postal Code
422 009
Country
India
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Research Site
City
Roma (RM)
ZIP/Postal Code
00133
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Research Site
City
Liepaja
ZIP/Postal Code
3400
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1004
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1005
Country
Latvia
Facility Name
Research Site
City
Valmiera
ZIP/Postal Code
4201
Country
Latvia
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
44320
Country
Lithuania
Facility Name
Research Site
City
Vilnius
ZIP/Postal Code
04130
Country
Lithuania
Facility Name
Research Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64040
Country
Mexico
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8022
Country
New Zealand
Facility Name
Research Site
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Research Site
City
Kongsvinger
ZIP/Postal Code
2226
Country
Norway
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Research Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-901
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
014461
Country
Romania
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
127299
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
129327
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Research Site
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
Research Site
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
Research Site
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Research Site
City
Newcastle
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Research Site
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Research Site
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Research Site
City
Stanmore
ZIP/Postal Code
HA7 4LP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32358413
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.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
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Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
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