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A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Primary Objective: To characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysisSecondary Objective: To characterize the long-term efficacy of AMG 416 on intact parathyroid hormone (…

18F-Choline PET/CT for patients with primary hyperparathyroidism and negative SPECT/CT

The primary objective of our study is to investigate the performance of FCH-PET as a second-line imaging modality for localizing hyper-functioning parathyroid gland(s) in patients with biochemically proven PHP for whom surgery is indicated, thereby…

A Multicenter single-arm Extension Study to Describe the Long-term Safety
of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With
Chronic Kidney Disease on Hemodialysis.

Primary: characterize the long-term safety and tolerability of AMG 416 in the treatment of secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis.Secondary: to characterize intact parathyroid hormone (iPTH…

A single center two part study in healthy adult male subjects to determine the human mass balance and pharmacokinetics of a single oral dose of 14C-KHK75801 (Part 1) and to assess the absolute bioavailability based on the pharmacokinetic parameters of a single intravenous microdose of 14CKHK7580 following a single oral dose of KHK7580 (Part 2)

The purpose of Part 1 of the study is to investigate how quickly and to what extent KHK7580 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The compound to be administered will be…

Efficacy and safety of treatment with Cinacalcet in patients with Primary Hyperparathyroidism due to a MEN-1 mutation

1. What are the effects of cinacalcet on clinical and biochemical parameters, including bone turnover markers, in patients with primary hyperparathyroidism due to a MEN-I mutation?2. What are the effects of cinacalcet on bone mineral density and…

The use of an iodine 125 marker for perioperative localization in primary hyperparathyroidism, a pilot study.

To facilitate the localization of a parathyroid adenome during surgery (MIP) with a radioactive iodine 125 (I-125) marker. This marker is placed preoperatively ultrasound guided in the affected parathyroid gland, and can be detected with a gamma…

PaRatHyroidectomy versus cInacalcet for the correctioN of secondary hyperparathyrOidism in end-stage renal disease patients (RHINO-trial), a pilot-study

The aim of the RHINO trial is to compare the effect of parathyroidectomy and cinacalcet treatment on quality of life in end-stage renal disease patients with hyperparathyroidism and to evaluate cost-effectiveness. The aim of this pilot study is to…

The validation and implementation of the Dutch version of the Quality of Life questionnaire for patients with primary hyperparathyroidism (PHPQoL)

Primary objective: To validate a disease-specific HRQoL questionnaire i.e., the PHPQoL, in a Dutch cohort.Secondary objective: To determine the effect of surgery, medical treatment or conservative treatment in patients with PHPT within our CCT.

Prospective, primarily direct comparison of 11C-methionine PET versus
11C-choline PET, and secondary 4D-CT, to explore what PET tracer to use
and in which order to use the functional versus the anatomical imaging
technique in the setting of primary hyperparathyroidism

Prospective, primarily direct comparison of 11C-methionine PET versus 11C-choline PET, and secondary 4D-CT, to explore what PET tracer to use and in which order to use the functional versus the anatomical imaging technique in the setting of primary…