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Hyperparathyroidism, Secondary clinical trials

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NCT ID: NCT05549154 Recruiting - Clinical trials for Vitamin D Deficiency

A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation

Start date: December 5, 2022
Phase: N/A
Study type: Interventional

1. Study content: This is a multicentre, double-blind, randomised controlled study to determine the optimal dose and duration of treatment for the correction of vitamin D insufficiency or deficiency in patients with CKD5d; to investigate whether vitamin D supplementation delays the increase in PTH levels in this group of patients; and to investigate the effects on changes in CKD-MBD-related markers, cardiovascular complications, cognitive function in this group of patients. 2. Study procedure: Based on the inclusion and exclusion of the patients, the study was conducted in accordance with the following criteria 2. Study procedure: Eligible subjects were screened according to inclusion and exclusion criteria and randomly divided into three groups: high-dose vitamin D group, low-dose vitamin D group and control group. Baseline data were collected before the intervention and each group was given different doses of regular vitamin D2 softgels or placebo and followed up. 25(OH)D, PTH, blood Ca, and blood P levels were measured every month; bone metabolism markers, FGF23, and blood counts, liver function, kidney function, lipids, and blood glucose were measured every 3 months; the prevalence of vascular calcification, the incidence of cardiovascular events, and changes in cognitive function scale scores were assessed 6 months after the intervention.

NCT ID: NCT05543928 Recruiting - Clinical trials for Vitamin d Deficiency

Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism

Start date: January 31, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.

NCT ID: NCT05540795 Completed - Clinical trials for Secondary Hyperparathyroidism

Diagnostic Accuracy of 3T MR for Secondary Hyperparathyroidism Comparison With 4DCT

Start date: February 6, 2023
Phase:
Study type: Observational

Secondary hyperparathyroidism (SHPT) is a common serious complication in the maintenance process of hemodialysis patients, characterized by diffuse or nodular hyperplasia of parathyroid glands. Parathyroidectomy for patients with drug-refractory SHPT is recommended in the clinical practice guidelines of the Global Organization for Improving Prognosis in Kidney Disease (KDIGO) and the Japanese Dialysis Therapy Society (JSDT) . Therefore, accurate localization and detection of parathyroid abnormalities is the key to avoid persistent recurrence of the disease. However, the sensitivity and specificity of the existing ultrasound and 99MTC-MIBI diagnosis are limited. CT examination is radiative and requires iodine contrast medium with nephrotoxicity, which may require timely dialysis and long-term monitoring for hemodialysis patients. 3T MRI has no radiation and does not need to use iodine contrast agent, which can well detect parathyroid lesions . Previous studies have reported that 3T MRI can diagnose primary hyperparathyroidism (PHPT), but the diagnostic efficacy of SHPT is still unclear. Therefore, this study aims to evaluate the preoperative diagnostic value of non-enhanced 3T MRI compared with 4DCT in patients with secondary hyperparathyroidism after hemodialysis.

NCT ID: NCT05382988 Completed - Hyperkalemia Clinical Trials

Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy

SZC
Start date: November 2016
Phase: Phase 3
Study type: Interventional

Sodium zirconium cyclosilicate (SZC) has been demonstrated for its serum potassium-lowering efficacy and safety in hyperkalemia hemodialysis patients. However, the effects of SZC during the perioperative period remained unknown. This experiment aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX).

NCT ID: NCT05347082 Completed - Clinical trials for Postmenopausal Osteoporosis

Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

Start date: April 29, 2021
Phase: N/A
Study type: Interventional

Recently, an increase in the prevalence of hyperparathyroidism and hypovitaminosis D in postmenopause women has been occurring in Mexico and the world. Chronic exposure to the parathyroid hormone (PTH) is catabolic for the bone, worsening the state of osteoporosis. However, it is unclear whether these conditions could significantly improve bone mineral density (BMD). In the present work, it was shown that the resolution of hyperparathyroidism in postmenopausal women improves osteoporosis.

NCT ID: NCT05221008 Completed - Clinical trials for Secondary Hyperparathyroidism

A Trial of SHR6508 in Secondary Hyperparathyroidism

Start date: March 10, 2022
Phase: Phase 1
Study type: Interventional

The study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis

NCT ID: NCT04994080 Not yet recruiting - Clinical trials for Secondary Hyperparathyroidism

A Study to Assess the Efficacy and Safety of Paricalcitol in the Treatment of Chronic Kidney Disease With Secondary Hyperparathyroidism

Start date: February 1, 2022
Phase: Phase 3
Study type: Interventional

The study is being conducted to evaluate the efficacy, and safety of Paricalcitol for secondary hyperparathyroidism with stage 3 and stage 4 chronic kidney disease in adults.

NCT ID: NCT04922892 Recruiting - Clinical trials for Secondary Hyperparathyroidism;Parathyroidectomy

Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Total parathyroidectomy with autotransplantation (TPTX+AT) and Total parathyr- oidectomy alone (TPTX) are the common surgical procedures.The purpose of the study was to compare the long-term benefits of surgery between the two groups.

NCT ID: NCT04750460 Completed - Clinical trials for Secondary Hyperparathyroidism

Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).

TeriCa
Start date: March 1, 2021
Phase: Phase 3
Study type: Interventional

This is a pilot randomized controlled trial aimed to evaluate the effect of teriparatide on the clinical course of hypocalcemia after parathyroidectomy for secondary hyperparathyroidism in dialysis-dependent patients.

NCT ID: NCT04637360 Completed - Clinical trials for Hyperparathyroidism; Secondary, Renal

Bone Markers and Bone Density Changes in Hyperperparathyroid Dialysis Patients Under Cinacalcet Treatment

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Chronic kidney disease related mineral and bone disorders (CKD-MBDs) and secondary hyperparathyroidism (SHPT) are observed in most patients with chronic kidney disease on dialysis (CKD-5D). The original use of the calcimimetic cinacalcet in these patients was to reduce the elevated parathyroid hormone (PTH) levels; however, subsequent clinical studies consistently confirmed its beneficial effects on mineral disturbances and bone disease. Although many mechanisms proposed, its specific mechanisms underlying the bone disease is still unclear. Recently, Wnt signaling and their inhibitors were proposed to involve in fine control of osteoclast-to-osteoblast cross-talk. In previous study, investigators explore the changes in Wnt 10b in bone microenvironment after addition of calcimimetic cinacalcet using in vitro osteoclasts. In vitro results were confirmed in 5/6 nephrectomy mice, which were grouped into control, with cinacalcet and without cinacalcet groups. From in-vitro study, investigators found cinacalcet increase mineralization; enhance osteoclast apoptosis, which probably work as osteoclast-osteoblast cross talk for bone formation. Similar results were found in-vivo animal study, and the micro-CT of cinacalcet treated CKD animals revealed a significantly decrease in cortical porosity. On the basis of our in-vitro and animal study, investigators propose that cinacalcet have definitive role on bone turnover marker and bone density changes among SHPT dialysis patients. Methods: Our study includes 50 hyperparathyroid dialysis patients using cinacalcet from 1st Dec 2017 to 31 Oct 2018. Investigators will exclude post-menopausal female subjects. Enzyme-linked immunosorbent assay and Western blot analysis will be done for bone turnover markers (TRACP,Alk-P,S1P,BMP6,Wnt,10B,16,SOST,P1NP,PDGF BB,HGF and CTHRC1, etc.). Bone mineral density will be determined by dual-energy X-ray absorptiometry (DXA). Plasma fibroblast growth factor (FGF-23), Ca 2+ , P 3+ , calcium-phosphorus product and parathyroid hormone will also be measured. Data will be collected and analyzed the differences between baseline measures and 4 weekly and follow up for 6 months after the treatment. Control group that we enrolled 30 hyperparathyroid dialysis patients using traditional therapy active vitamin D without use cinacalcet.