Clinical trial NCT01081678: Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fracture Healing
Keywords: AMG 785
Proximal Femur
Fracture Healing
Hip Fracture
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 332
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.


Eligibility criteria: 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

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

Primary outcomes:
measure: Timed-Up-and-Go (TUG) Over Week 6 Through Week 20
timeFrame: Weeks 6, 12, 16, and 20
Secondary outcomes:
measure: Timed-Up-and-Go (TUG) at Each Visit
timeFrame: Weeks 2, 6, 12, 16, 20, 24, 36, and 52
measure: Time to Radiographic Healing
timeFrame: 52 weeks
measure: Radiographic Union Scale for Hip (RUSH) Score At Each Visit
timeFrame: Weeks 2, 6, 12, 16, 20, 24, 36, and 52
measure: Harris Hip Score At Each Visit
timeFrame: Weeks 2, 6, 12, 16, 20, 24, 36, and 52
measure: Hip Pain Score at Each Visit
timeFrame: Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Pomona
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: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Woodbury
country: United States
facility: Research Site
state: Minnesota
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: State College
country: United States
facility: Research Site
state: Pennsylvania
city: Buenos Aires
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: Liverpool
country: Australia
facility: Research Site
state: New South Wales
city: Footscray
country: Australia
facility: Research Site
state: Victoria
city: Brugge
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: LiÃ¨ge
country: Belgium
facility: Research Site
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Red Deer
country: Canada
facility: Research Site
state: Alberta
city: Cambridge
country: Canada
facility: Research Site
state: Ontario
city: Guelph
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
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: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Quebec
country: Canada
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: KÃ¸benhavn NV
country: Denmark
facility: Research Site
city: Viborg
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: Kuopio
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Muenchen
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: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mangalore
country: India
facility: Research Site
state: Karnataka
city: Nashik
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
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: Roma (RM)
country: Italy
facility: Research Site
city: Verona
country: Italy
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: Amsterdam
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Haarlem
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: KrakÃ³w
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Celje
country: Slovenia
facility: Research Site
city: Izola
country: Slovenia
facility: Research Site
city: Jesenice
country: Slovenia
facility: Research Site
city: Sempeter pri Gorici
country: Slovenia
facility: Research Site
city: LinkÃ¶ping
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Luzern
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Barnet
country: United Kingdom
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
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.