EUCTR2009-015939-33-LV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 - Study To Assess FRacTure Healing with SclerosTin Antibody - Hip (STARTT-Hip)
适应症
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 consent
- •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 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
- •- 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 fracture fixation
- •- Subjects to be
研究者
相似试验
进行中（未招募）
不适用
A Multi-center, Randomized, Double-blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation with an Intramedullary Nail - AMG 785 20062017Acceleration of fracture healingMedDRA version: 12.1Level: LLTClassification code 10043827Term: Tibia fractureEUCTR2008-008392-34-ITAmgen Inc.400
进行中（未招募）
1 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation with an Intramedullary Nail - Study To Assess Healing of Repaired Tibias with SclerosTin Antibody (STARTT) - Study To Assess Healing of Repaired Tibias with SclerosTin Antibody (STARTT)Acceleration of fracture healingMedDRA version: 13.1 Level: PT Classification code 10043827 Term: Tibia fracture System Organ Class: 10022117 - Injury, poisoning and procedural complicationsEUCTR2008-008392-34-GBAmgen Inc400
进行中（未招募）
不适用
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (erlotinib) Following Complete Tumor Resection and with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-small Cell Lung Carcinoma who have EGFR-positive Tumors.Estudio fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de una monoterapia con Tarceva® (erlotinib) tras una resección tumoral completa, con o sin quimioterapia adyuvante, en pacientes con cáncer de pulmón de células no pequeñas en estadios IB-IIIA que tienen tumores EGFR-positivo. - RADIANTEUCTR2005-001747-29-ESOSI Pharmaceuticals, Inc.945
进行中（未招募）
1 期
/aEUCTR2015-005241-31-NOEryDel S.p.A.175
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 NailEUCTR2009-015939-33-SEAmgen Inc330