EUCTR2011-001116-65-PL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
- 40
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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
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 to Visit 1
- •-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
- •- Associated major injuries of a lower extremity including fractures of the foot, ankle, tibia, fibula, knee, femur, femoral head, or pelvis: dislocations of the ankle, knee, or hips.
研究者
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