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

JRCT ID: jRCTs011230047

Registered date:14/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Kidney Disease
• Date of first enrollment: 14/11/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• 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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Nishio Saori