EUCTR2008-008392-34-BG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 - Study To Assess Healing of Repaired Tibias with SclerosTin Antibody (STARTT) - Study To Assess Healing of Repaired Tibias with SclerosTin Antibody (STARTT)
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
- 400
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
- •Skeletally mature adults, age = 18 to = 85 years at randomization, with radiographically closed growth plates.
- •Fresh unilateral closed or Gustilo type I or type II open tibia diaphyseal fracture (fracture line must not extend into the ankle or knee joint) as the primary injury.
- •For closed fractures: Definitive fracture fixation with reamed IM nailing (modern, statically, interlocking nail) performed no later than 14 days after injury.
- •For Gustilo type I/II open fractures: Definitive fracture fixation with reamed or unreamed IM nailing (modern, statically, interlocking nail) performed no later than 24 hours after injury.
- •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 370
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Major polytrauma or significant axial trauma, with injury severity score >16
- •Head-injury, as defined by Glasgow Coma Scale <13 at time of randomization
- •Associated fracture of the lower extremity or any other condition that, in the opinion of the surgeon, will delay the subject’s ability to bear weight beyond the normal time expected for a tibial shaft fracture
- •Use of bone grafts at the time of definitive fracture fixation
- •History of pathological fracture or metabolic or bone disease that may interfere with the interpretation of the results, such as Paget’s disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, 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 any 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 (AST; serum glutamate-oxaloacetic transaminase [SGOT]) = 2.0 x upper limits of normal; (b) Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase [SGPT]) = 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].
- •Per subject report, chart review or local laboratory result, evidence of current hypercalcemia or hypocalcemia, outside of 1.1x 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:
- •Intravenous bisphosphonates at any time
- •Denosumab at any time
- •Fluoride (for osteoporosis) within the past 24 months
- •Oral bisphosphonates, parathyroid hormone or strontium within the past 12 months
- •Calcitonin, selective estrogen receptor modulators, systemic oral or transdermal estrogen within the past three months (estrogen-containing contraceptive therapy is permitted)
- •Systemic glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10 days) within the past three months
- •Tibolone within the past three months
- •BMP-2 or BMP-7 at the time of definitive fracture fixation
- •Current use of anticoagulants (doses for deep vein thrombosis prophylaxis are permitted)
- •Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
- •Previous enrollment in an AMG 785 clinical study
- •Subject of child-bearing potential who is pregnant (eg, positive human chorionic gonadotropin test) or is breast-feeding
- •Females of childbearing potential: Subject refuses to use an effective contraception (or true abstinence) in o
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