Safety and efficacy of twice-weekly teriparatide in hemodialysis patients with osteoporosis

ishio Saori0 个研究点目标入组 50 人开始时间: 2023年11月14日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•1)HD patients who have fragile fracture or low BMD (BMD less than 70% of
•young adult mean or less than -2.5 SDs), according to the criterion for the diagnosis of primary osteoporosis (revised 2015 prevention and treatment guidline for osteoporosis)
•2)Patients who CKD-MBD are appropriately treated (intact PTH level <240 pg/mL) (oral vitamin D use is permitted)
•3)Therapy for secondary hyperparathyroidism including calcimimetics or intravenous vitamin D use is excluded
•4)Patients age >= 20 years
•5)Pattients who can walk by themselves
•6)Any primary cause of ESRD is included
•7)Patients from whom written informed consent was obtained

•1)Risk for osteosarcoma, such as Paget,s disease of the bone, unexplained elevations of serum alkaline phosphatase levels, pediatrics and young adult patients with open epiphysis, or prior external beam or implant radiation therapy involving the skeleton
•2) Hypercalcemia
•3)The presence of bone cancers or metastatic bone tumors
•4)Patients with metabolic bone diseases other than osteoporosis(hyperparathyroidism etc.)
•5)Hypersensitivity to teriparatide or its excipients
•6)Pregnant women and women suspected of being pregnant
•7)Patients deemed inadequate for monitoring during study period, as determined by investigators.

发起方

ishio Saori