Chronic Kidney Disease
Conditions
Interventions
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
Sponsors
Nishio Saori
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of change in BMD at the lumbar spine from baseline at week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactMichiko Kurotori
Hokkaido university hospital
Outcome results
None listed