Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo para determinar la eficacia, seguridad y tolerabilidad de AMG 785 en adultos con fractura de cadera unilateral reciente, posterior a fijación quirúrgica

CompletadoFase 2ClinicalTrials.gov

ID: NCT01081678Tipo: INTERVENTIONALInicio: 20 de jun de 2010Fin estimado: 10 de may de 2013

Resumen

Este es un estudio internacional, multicéntrico para determinar la eficacia, seguridad y tolerabilidad de romosozumab (AMG 785) en adultos con fractura de cadera unilateral reciente, posterior a fijación quirúrgica.

Elegibilidad

Edad mínima: 55 YearsEdad máxima: 95 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Placebo

Administered by subcutaneous (under the skin) injection

drug

Romosozumab

Administered by subcutaneous injection

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Patrocinadores

PrincipalAmgen

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