EUCTR2007-001477-29-SE进行中（未招募）不适用
A proof-of-concept study of SB-751689 in men and post-menopausal women with a fractured distal radius.
GlaxoSmithKline R & D Limited0 个研究点目标入组 219 人开始时间: 2007年5月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 219
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
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •1. Informed Consent: Subject is willing and able to provide written informed consent
- •2. Fracture type: Extra-articular distal radius fractures AO/ASIF types 23-A2 and 23-A3
- •are permissible. (Arbeitsgemeinschaft für Osteosynthesefragen (AO)/ Association for
- •the Study of Internal Fixation (ASIF))
- •3. Fracture treatment: Received conservative treatment of the distal radius fracture,
- •including closed reduction and immobilization device (such as cast, splint, or brace)
- •4. Men or Women: Ambulatory males aged =35 to < 80years of age OR ambulatory
- •post menopausal females who have sustained a closed, unilateral, fracture of the distal radius no more than 5 days prior to randomisation
- •Post menopausal defined as: female aged = 35 but < 80 years at screening and
- •>1 year post-menopausal, which can be >1 year of spontaneous amenorrhea or
- •> 1 year post surgical bilateral oophorectomy. Use follicle stimulating hormone
- •[FSH] levels >40 mIU/mL to confirm surgical post-menopausal status, where
- •bilateral oophorectomy status is uncertain. Females of child bearing potential must have a negative beta hCG pregnancy test at the screening visit and agree to practice acceptably highly effective methods of birth control throughout the duration of the study. Highly effective birth control methods include those preventative measures taken to avoid pregnancy that have a failure rate of less than 1% per year. 5. Protocol compliance: Subject who, in the opinion of the investigator, is willing and
- •able to comply with the requirements of the protocol, including ability to understand patient reported outcomes (PRO) questionnaires
- •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
- •Any treatment of a fracture that occurred more than 5 days after the fracture sustaining injury, all B- and C-type fractures that would likely require open reduction and internal fixation, prior fracture of the same wrist as an adult, placement of hardware (pins or plates)
- •History/current conditions: synovial pseudoarthrosis, congenital pseudoarthrosis, or active osteomyelitis, diseases affecting bone metabolism, skeletal immaturity or pathologic fracture, arthritis - active disease or inflammatory joint disease, TSH <0.1 or >10.0 IU/L, nephrolithiasis, increased risk of osteosarcoma, malignant disease, malabsorption syndrome, liver disease or known hepatic or biliary abnormalities, drug or alcohol abuse, risk factors for Torsades de Pointes, marked baseline prolongation of QT/QTc interval, certain surgical/medical conditions (myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, cardiac arrhythmia, congestive heart failure, cardiac pacemaker, or stroke), neurological diseases, biological abnormality (HIV, significant mental illness), inability to swallow,
- •Use of the following medications, some have time restrictions associated with their use : treatment with strontium ranelate or intravenous bisphosphonate, oral bisphosphonate, fluoride, PTH, PTH analogues, chronic systemic steroids, hormones estrogens/natural estrogen preparations, cyclosporine, tacrolimus, methotrexate, clarithromycin, erythromycin, telithromycin, prior investigational drug usage, vitamin A in excess of 10,000 IU per day, heparin, lithium, anticonvulsant medications, nefazodone, digoxin, NSAIDs, inability to tolerate with calcium or vitamin D, cyclosporine or diltiazem, verapamil, cyclosporine, oral tacrolimus, ritonavir, quinidine, all oral azole antifungal, birth control (strongly recommended), raised serum calcium outside local lab range, raised ALT or AST above 2 fold the upper limit of local lab ref range, GFR<35ml/min
研究者
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