NL-OMON36359已完成2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral Hip Fracture, Status Post Surgical Fixation - Assessing healing itc hip fractures w Sclerostin Antibody
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Adult women or men, age >= 55 to <= 95 years at randomization
- •-Fresh unilateral low energy intertrochanteric or femoral neck fractures 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 fractures
- •-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
- •ntertrochanteric fracture: sliding hip screw or intermedullary nail
- •femoral neck fracture: sliding hip screw or at least three cancellous screws
- •-Pre- and postoperative care performed as defined in Appendix J in the protocol
- •-Subject or subject's legally acceptable representative has provided informed consent
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 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 asymtomatic 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
- •-hypocalcemia or hypercalcemia, outside of 1.1 x the normal range set by the local laboratory
- •-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)
- •-BMP-2 or BMP-7 at the time of definitive fracture fixation
- •-Subjects to be enrolled in DXA sub-study may not have had previous
- •instrumentation with implants (ie, nails, screws, pins, plates) to either hip or lower
- •-Subject has known sensitivity to any of the products to be administered
- •(calcium supplements, vitamin D products, or mammalian cell derived
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