Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
NCT ID: NCT01081678
Last Updated: 2022-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
332 participants
INTERVENTIONAL
2010-06-20
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 placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Placebo
Administered by subcutaneous (under the skin) injection
Romosozumab 70 mg
Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Romosozumab
Administered by subcutaneous injection
Romosozumab 140 mg
Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Romosozumab
Administered by subcutaneous injection
Romosozumab 210 mg
Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Romosozumab
Administered by subcutaneous injection
Interventions
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Placebo
Administered by subcutaneous (under the skin) injection
Romosozumab
Administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
55 Years
95 Years
ALL
No
Sponsors
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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
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Pomona, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Indianapolis, Indiana, United States
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Woodbury, Minnesota, 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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State College, Pennsylvania, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Liverpool, New South Wales, Australia
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Footscray, Victoria, Australia
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Bruges, , Belgium
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Genk, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Liège, , Belgium
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Blagoevgrad, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Red Deer, Alberta, Canada
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Cambridge, Ontario, Canada
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Guelph, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, 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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Viborg, , Denmark
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Tallinn, , Estonia
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Tartu, , Estonia
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Kuopio, , Finland
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Oulu, , Finland
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Turku, , Finland
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Aachen, , Germany
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Berlin, , Germany
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München, , 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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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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Jaipur, Rajasthan, 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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Roma (RM), , Italy
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Verona, , Italy
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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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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Haarlem, , Netherlands
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Nieuwegein, , Netherlands
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Christchurch, , New Zealand
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Kraków, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Celje, , Slovenia
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Izola, , Slovenia
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Jesenice, , Slovenia
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Šempeter pri Gorici, , Slovenia
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Linköping, , Sweden
Research Site
Lund, , Sweden
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Basel, , Switzerland
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Lausanne, , Switzerland
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Lucerne, , Switzerland
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Zurich, , Switzerland
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Barnet, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Newcastle, , United Kingdom
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Norwich, , United Kingdom
Countries
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References
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Schemitsch EH, Miclau T, Karachalios T, Nowak LL, Sancheti P, Poolman RW, Caminis J, Daizadeh N, Dent-Acosta RE, Egbuna O, Chines A, Maddox J, Grauer A, Bhandari M. A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures. J Bone Joint Surg Am. 2020 Apr 15;102(8):693-702. doi: 10.2106/JBJS.19.00790.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20080394
Identifier Type: -
Identifier Source: org_study_id
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