EUCTR2011-001116-65-HU进行中（未招募）不适用
Second study on the Effect of Teriparatide on Femoral Neck Fracture Healing - GHDQ
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,220
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
- •-Community dwelling men and postmenopausal women aged = 50 years who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or non-displaced)
- •-Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 years
- •-Have received or are eligible for treatment with internal fixation (sliding hip screw or multiple cancellous screws) for the femoral neck fracture (the surgical procedure itself is not a part of this protocol)
- •-Have given written informed consent (patient or proxy) after being informed of the risks, medications and study procedures
- •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 610
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 610
排除标准
- •-Increased baseline risk of osteosarcoma; this includes patients with
- •Paget's diseaseof the bone, previous primary skeletal malignancy, or
- •skeletal exposure to therapeutic irradiation, including external beam
- •therapy or brachytherapy. As elevation of serum alkaline phosphatase
- •may indicate the presence of Paget's disease, an unexplained elevation
- •of this enzyme is also exclusionary.
- •-History of unresolved skeletal diseases affecting bone metabolism other
- •than primary osteoporosis including renal dystrophy, osteomalacia,
- •including glucocorticoid-induced osteoporosis, hyperparathyroidism
- •(uncorrected), and intestinal malabsorption
- •-Abnormally elevated values of serum calcium at baseline defined as =
- •10,6 mg/dL, except for clinically insignificant values as determined by
- •the investigator in conjunction with the Lilly clinical research physician
- •-Abnormally elevated values of serum intact parathyroid hormone (PTH)
- •(1-84) at baseline defined as >72 pg/mL
- •-Severe vitamin D deficiency at baseline defined as 25-hydroxy-vitamin
- •D levels <9,2 ng/mL
- •-Active liver disease or jaundice
- •-Significantly impaired renal function at baseline based on serum
- •creatinine and/or measured or calculated creatininethat, in the opinion
- •of investigator, indicates significant renal impairment
- •-Abnormal thyroid function not corrected by therapy
- •-History of malignant neoplasm in the 5 years prior to Visit 1, with the
- •exception of superficial basal cell carcinoma or squamous cell carcinoma
- •of the skin that has been definitively treated. Patients with carcinoma in
- •situ of the uterine cervix treated definitively more than 1 year prior to
- •screening may enter the study.
- •-History of bone marrow or solid-organ transplantation
- •-History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior
- •-Previous treatment with the following bone active drugs is allowed but
- •must be discontinued at Visit 1: oral bisphosphonates, selective estrogen
- •receptor modulators, calcitonin, estrogen (oral, transdermal or
- •injectable), progestin, estrogen analog, estrogen agonist, estrogen
- •antagonist or tibolone, and active Vit D analogues. Androgen or other
- •anabolic steroid use must be discontinued, except for use of physiologic
- •replacement testosterone.
- •-Previous treatment with the following bone active drugs is
- •exclusionary, if the stated treatment durations have been met: strontium
- •ranelate for any duration, intravenous bisphosphonates in the 12 months
- •preceding Visit 1, and/or denosumab in the 6 months preceding Visit 1
- •-Prior treatment with PTH, teriparatide, or other PTH analogs, or prior
- •participation in any other clinical trial studying PTH, teriparatide or other
- •PTH analogs
- •-Local or systemic treatment with bone morphogenic proteins or any
- •other growth factor
- •-Previous fracture(s) or bone surgery in the currently fractured hip
- •-Soft-tissue infection at the operation site
- •-Treatment with bone grafting or osteotomies
- •-Treatment with augmentation using any type of degradable cement,
- •hydroxyapatite-coated implants, or with noninvasive interventions
- 另有 3 项未显示
研究者
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