Effect of Teriparatide on Femoral Neck Fracture Healing - GHD

illy S.A.0 个研究点目标入组 122 人开始时间: 2011年11月22日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•Community dwelling men and postmenopausal women aged ?50 years who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture
•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
•Have given written informed consent
•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

•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
•Polytrauma patients and patients with fracture at more thatn 1 site.

发起方

illy S.A.