EUCTR2009-015939-33-SE进行中（未招募）不适用
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine theEfficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral Intertrochanteric Fracture of the Proximal Femur, Status Post Fixation with a Sliding Hip Screw or Intramedullary Nail
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 = 90 years at randomization
- •Fresh unilateral low energy intertrochanteric fracture of the proximal femur as the primary injury, confirmed by X-ray
- •Fractures eligible for this study must have one of the following characteristics
- •At least three fragments, each with displacement = 1 cm
- •Extension into the subtrochanteric region
- •Internal fixation of the fracture with a sliding hip screw or IM nail (devices
- •approved by local regulatory agency), performed no later than 5 days after injury
- •Pre- and postoperative care performed as defined in Appendix J of the protocol
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
- •Adult women or men, age = 55 to = 90 years at randomization
- •Fresh unilateral low energy intertrochanteric fracture of the proximal femur as the primary injury, confirmed by X-ray
- •Fractures eligible for this study must have one of the following characteristics
- •At least three fragments, each with displacement = 1 cm
- •Extension into the subtrochanteric region
- •Internal fixation of the fracture with a sliding hip screw or IM nail (devices
- •approved by local regulatory agency), performed no later than 5 days after injury
- •Pre- and postoperative care performed as defined in Appendix J of the protocol
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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
- •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 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
- •Evidence of the following per subject report, chart review or local laboratory
- •result (currently or within the past 5 years)
- •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].
- •Current hypocalcemia or hypercalcemia (= 1.1 x upper limit of the normal
- •range set by the local laboratory, after adequate volume resuscitation, is
- •acceptable for high calcium value)
- •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
- •Denosumab within the past 6 months
- •Fluoride (for osteoporosis) or IV bisphosphonates within the past 12 months
- •Parathyroid hormone or strontium within the past 12 months
- •Calcitonin within the past three months
- 另有 58 项未显示
研究者
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