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

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Enrollment assignment will be made after obtaining consent and patient enrollment. On the observation start date (Week 0), a bone mineral density test will be performed and the study subjects will be divided into two groups: a pre‐treatment group who will start Teriparatide at week 0 for 1 year, and a late treatment(control) group who will start Teriparatide after the 1‐year observation period. The pre‐treatment group will be observed for approximately one year and the late treatment group will be followed for approximately 2 years. CONDITION: Chronic Kidney Disease PRIMARY OUTCOME: the rate of change in BMD at the lumbar spine from baseline at week 48 SECONDARY OUTCOME: The following rate of change between 0 week and each point of time in the prior group and control group; 1)echocardiogram parameters (LVDd(mm) LVD(s mm) LVEF(%) LAD(mm) LAV(I mL/m2) E/e,E/A), cardiothoracic ratio; 2) arterial clcification in thoracic CT; 3)CVD biomarker; 4)incidence of fracture; 5)bone turnover markers; 6)the rate of change in BMD at the lumar spine and femoral neck from baseline(prior group week0 to week48, control group week48 to week96) INCLUSION CRITERIA: 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
Epistemonikos ID: d1502eb9b0404af13d971b98c9df512ce3454086
First added on: Aug 28, 2024