Regulation of Bone Formation in Renal Osteodystrophy
Secondary HyperparathyroidismRenal OsteodystrophyTo examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3...
Secondary HyperparathyroidismRenal Failure1 moreThe purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients...
Secondary HyperparathyroidismEnd Stage Renal DiseaseThis 6 month study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis...
Secondary HyperparathyroidismEnd Stage Renal DiseaseThis 6 month long study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary...
Secondary HyperparathyroidismChronic Kidney DiseaseThe primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by > 30% from baseline among participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided...
Primary HyperparathyroidismThyroid Disease2 moreThe radio-guided technique offers both help with in-vivo identification and ex-vivo confirmation of parathyroid adenoma. In-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.
The Bone-parathyroid Crosstalk in Primary Hyperparathyroidism
HyperparathyroidismPrimary2 moreThe PARABONE study aims to investigate the interaction between bone and parathyroid glands in patients with primary hyperparathyroidism (HPT). The study consists of a clinical part aimed at evaluating a series of circulating molecules of bone derivation (osteocalcin, molecules of the WNT pathway, RANKL, osteoprotegerin, Scelrostin, FGF23) in patients with HPT. In particular, the study has as its primary objective to identify the correlation between circulating levels of PTH and levels of GlaOC and GluOC in patients with HPT.
Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.
Primary HyperparathyroidismParathyroid Adenoma1 moreThe only known cure for primary hyperparathyroidism is surgical removal of one or more parathyroid glands. Some patients however, do not fulfill criteria for surgery or do not want to undergo a procedure due to fear of the associated risks. Therefore a medical alternative is warranted. This study aims to evaluate the effects of Denosumab alone, and in combination with Cinacalcet, as a medical treatment for patients suffering from primary hyperparathyroidism, with mild osteoporosis. To the best of our knowledge no previously reported randomized controlled trial has investigated the use of denosumab in primary hyperparathyroidism. 60 patients will be enrolled in three different treatment-groups: 20 receiving both Denosumab and Cinacalcet, 20 Denosumab and placebo and 20 placebo and placebo. Patients included do not meet the criteria for, or have no wish for a surgical procedure. By combining the two drugs, this study could possibly contribute to the discovery of a realistic medical alternative to surgery. It is expected that the therapy will be able to both control s-calcium and s-intact parathyroid hormone (iPTH), and simultaneously enhance bone-structure. The therapy thus has the potential of preventing fractures and possibly other long-term effects of primary hyperparathyroidism such as formation of kidney stones, and coronary calcification. Another objective of this project is to investigate whether the combined therapy can facilitate an actual reset of the Calcium-sensing receptor, and thereby de facto cure the disease.
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
Secondary HyperparathyroidismThis study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.
Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism
HyperparathyroidismPrimary1 moreTo assess the efficacy and safety of treatment with cinacalcet and with cinacalcet plus alendronate in controlling bone loss induced by primary hyperparathyroidism.