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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01081678




Registration number
NCT01081678
Ethics application status
Date submitted
4/03/2010
Date registered
5/03/2010
Date last updated
21/09/2022

Titles & IDs
Public title
Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
Scientific title
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults With a Fresh Unilateral Hip Fracture, Status Post Surgical Fixation
Secondary ID [1] 0 0
20080394
Universal Trial Number (UTN)
Trial acronym
STARTT-Hip
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: Drugs - Placebo
Treatment: Drugs - Romosozumab

Placebo comparator: Placebo - Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.

Experimental: Romosozumab 70 mg - Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.

Experimental: Romosozumab 140 mg - Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.

Experimental: Romosozumab 210 mg - Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.


Treatment: Drugs: Placebo
Administered by subcutaneous (under the skin) injection

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

Outcomes
Primary outcome [1] 0 0
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20
Timepoint [1] 0 0
Weeks 6, 12, 16, and 20
Secondary outcome [1] 0 0
Timed-Up-and-Go (TUG) at Each Visit
Timepoint [1] 0 0
Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Secondary outcome [2] 0 0
Time to Radiographic Healing
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Radiographic Union Scale for Hip (RUSH) Score At Each Visit
Timepoint [3] 0 0
Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Secondary outcome [4] 0 0
Harris Hip Score At Each Visit
Timepoint [4] 0 0
Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Secondary outcome [5] 0 0
Hip Pain Score at Each Visit
Timepoint [5] 0 0
Weeks 2, 6, 12, 16, 20, 24, 36, and 52

Eligibility
Key inclusion criteria
* Males and females, age 55 to 95 years
* fresh unilateral low energy intertrochanteric or femoral neck fracture as the primary injury, confirmed by X-ray and in the opinion of the treating surgeon amenable to repair by internal fixation
* internal fixation of the fracture with devices approved by local regulatory agency, performed no later than 7 days after injury for intertrochanteric or undisplaced femoral neck fractures and no later than 2 days after injury for displaced femoral neck fractures

* intertrochanteric fracture: sliding hip screw or IM nail
* femoral neck fracture: sliding hip screw or at least 3 cancellous screws
Minimum age
55 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* severe symptomatic osteoarthritis of the lower extremity
* inability to independently rise from armchair or walk 200 meters before hip fracture
* presence of concomitant injuries such as rib fractures, wrist fractures, or acute symptomatic vertebral fractures which severely impair the ability to rise from a chair
* associated extremity injuries including ipsilateral or contralateral fractures of the foot, tibia or fibula, wrist, humerus, femoral shaft, femoral head or hip dislocation, that may delay weight-bearing beyond one week after surgery
* head-injury, as defined by Glasgow Coma Scale < 13 prior to randomization
* use of bone grafts or bone substitutes at the time of fracture fixation
* major polytrauma or significant axial trauma, with Injury Severity Score > 16
* pathological fracture or history of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget's disease, rheumatoid arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia
* history of symptomatic spinal stenosis that has not been surgically corrected. If surgically corrected, the subject must be asymptomatic to be eligible for the study.
* history of facial nerve paralysis
* malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical carcinoma in situ) within the last 5 years
* history of solid organ or bone marrow transplants
* evidence of elevated transaminases (= 2.0 x upper limits of normal) or significantly impaired renal function (creatinine clearance of = 30 mL/min)
* evidence of current hypercalcemia or hypocalcemia (outside of 1.1 x the normal range)
* bone morphogenic proteins (BMP)-2 or BMP-7 at the time of definitive fracture fixation

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
20/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/05/2013
Sample size
Target
Accrual to date
Final
332
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Research Site - Liverpool
Recruitment hospital [2] 0 0
Research Site - Footscray
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3011 - Footscray
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
State/province [3] 0 0
Colorado
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United States of America
State/province [4] 0 0
Indiana
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United States of America
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Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
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New York
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United States of America
State/province [8] 0 0
Pennsylvania
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Argentina
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Buenos Aires
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Belgium
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Brugge
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Belgium
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Genk
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Liège
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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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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
Country [21] 0 0
Denmark
State/province [21] 0 0
Hvidovre
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Denmark
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København NV
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Denmark
State/province [23] 0 0
Viborg
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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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Finland
State/province [27] 0 0
Kuopio
Country [28] 0 0
Finland
State/province [28] 0 0
Oulu
Country [29] 0 0
Finland
State/province [29] 0 0
Turku
Country [30] 0 0
Germany
State/province [30] 0 0
Aachen
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Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Muenchen
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Germany
State/province [33] 0 0
Muenster
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Greece
State/province [34] 0 0
Athens
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Greece
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Larissa
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Greece
State/province [36] 0 0
Patra
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Greece
State/province [37] 0 0
Thessaloniki
Country [38] 0 0
Hong Kong
State/province [38] 0 0
Hong Kong
Country [39] 0 0
Hong Kong
State/province [39] 0 0
New Territories
Country [40] 0 0
Hungary
State/province [40] 0 0
Budapest
Country [41] 0 0
Hungary
State/province [41] 0 0
Miskolc
Country [42] 0 0
Hungary
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Nyiregyhaza
Country [43] 0 0
Hungary
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Szeged
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India
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Andhra Pradesh
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India
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Karnataka
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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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Mangalore
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India
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Nashik
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Italy
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Firenze
Country [51] 0 0
Italy
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Milano
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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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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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Netherlands
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Amsterdam
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Netherlands
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Haarlem
Country [60] 0 0
Netherlands
State/province [60] 0 0
Nieuwegein
Country [61] 0 0
New Zealand
State/province [61] 0 0
Christchurch
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Poland
State/province [62] 0 0
Kraków
Country [63] 0 0
Poland
State/province [63] 0 0
Lublin
Country [64] 0 0
Poland
State/province [64] 0 0
Warszawa
Country [65] 0 0
Slovenia
State/province [65] 0 0
Celje
Country [66] 0 0
Slovenia
State/province [66] 0 0
Izola
Country [67] 0 0
Slovenia
State/province [67] 0 0
Jesenice
Country [68] 0 0
Slovenia
State/province [68] 0 0
Sempeter pri Gorici
Country [69] 0 0
Sweden
State/province [69] 0 0
Linköping
Country [70] 0 0
Sweden
State/province [70] 0 0
Lund
Country [71] 0 0
Switzerland
State/province [71] 0 0
Basel
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Switzerland
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Lausanne
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Switzerland
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Luzern
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Switzerland
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Zurich
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United Kingdom
State/province [75] 0 0
Barnet
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Leeds
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United Kingdom
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London
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United Kingdom
State/province [78] 0 0
Newcastle
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01081678