Second study on the Effect of Teriparatide on Femoral Neck Fracture Healing - GHDQ

Eli Lilly0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•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

•Increased baseline risk of osteosarcoma;History of unresolved skeletal diseases affecting bone metabolism other than primary osteoporosis and any secondary causes of osteoporosis ;Abnormally elevated values of serum calcium at baseline ;Abnormally elevated values of serum intact parathyroid hormone (PTH) (1-84) at baseline ;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 ;Abnormal thyroid function not corrected by therapy;History of a 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.;History of bone marrow or solid-organ transplantation;History of symptomatic nephrolithiasis or urolithiasis in 1 year prior to visit;Prior treatment with PTH, teriparatide or other PTH analogs;Local or systemic treatment with bone morphogenic proteins or any growth factor;Previous fracture or bone surgery in the currently fractured hip;Treatment with bone grafting or osteotomies;Soft tissue infection at the operation site;Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants or with non-invasive interventations;Associated major injuries of a lower exteremity including fractures of teh foot, ankle, tibia, fibula, knee, femur, femoral head, or pelvis; dislocations of the ankle, knee, or hip.

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