EUCTR2009-015939-33-FI进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult women or men, age = 55 to = 95 years at randomization
- •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
- •Intertrochanteric fractures eligible for this study must have at least two displaced fragments
- •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 three cancellous screws
- •Pre- and postoperative care performed as defined in Appendix I
- •Subject or subject’s legally acceptable representative has provided informed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •Conditions that may affect the ability to perform functional or clinical
- •assessments required by the protocol, such as:
- •Severe symptomatic osteoarthritis of the lower extremity
- •Inability to independently rise from armchair or walk 200 meters before hip
- •fracture (use of unilateral assistive device or rolling walker is acceptable)
- •Cognitive deficit, as defined by Mini-Mental Status Examination score < 22 at
- •time of randomization
- •Symptomatic neurological conditions such as Parkinson’s disease or persistent
- •gross motor or sensory deficits such as hemiparesis or hemiplegia
- •Presence of concomitant injuries such as rib fractures, wrist fractures, or acute
- •symptomatic vertebral fractures which severely impair the ability to rise from a
- •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
- •Use of bone grafts or bone substitutes at the time of fracture fixation
- •Head-injury, as defined by Glasgow Coma Scale <13 prior to randomization
- •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
- •Severe asthma or severe chronic obstructive pulmonary disease or recent exacerbation
- •Myocardial infarction or unstable angina pectoris within the last 12 months
- •Current alcohol dependence
- •History of solid organ or bone marrow transplants
- •Per subject report, chart review or local laboratory result, evidence of currently abnormal values for the following:
- •Elevated transaminases (a) Serum aspartate aminotransferase = 2.0 x
- •upper limits of normal; (b) Serum alanine aminotransferase = 2.0 x upper
- •limits of normal
- •Significantly impaired renal function as determined by a derived creatinine
- •clearance of = 30 mL/min using the Modification of Diet in Renal Disease
- •equation (Levey et al, 1999). The estimated glomerular filtration rate is
- •calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2)
- •= 186 x [Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is
- •female] x [1.210 if subject is black].
- •Hypocalcemia or hypercalcemia, outside of 1.1 x the normal range set by the local laboratory
- •Known to have tested positive for human immunodeficiency virus, hepatitis C
- •virus, or hepatitis B surface antigen
- •- Use of the following agents affecting bone metabolism
- •Within the past 12 months: parathyroid hormone, strontium, fluoride (for osteoporosis)
- •Within the past 6 months: IV bisphosphonates, denosumab, odanacatib (MK-0822)
- •Within the past 3 months: calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10 days)
- •Bone Morphogenetic Protein (BMP)-2 or BMP-7 at the time of definitive f
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