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FDA Approves Rayaldee (calcifediol) to Treat Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease

MIAMI--(BUSINESS WIRE) June 21, 2016 -- OPKO Health, Inc. (NYSE:OPK) announced that the U.S. Food and Drug Administration (FDA) has approved Rayaldee (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT)...
Source: Drugs.com - New Drug Approvals - Category: Drugs & Pharmacology Source Type: news

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Parathyroidectomy (PTx) decreases the mortality rate of refractory secondary hyperparathyroidism (rSHP) due to chronic kidney disease. A consensus regarding which techniques of PTx are associated with better outcomes is not available. The aims of this study are to evaluate the clinical and laboratory evolution of 49 hemodialysis patients with rSHP who underwent PTx using different techniques.
Source: Surgery - Category: Surgery Authors: Tags: Original Communications Source Type: research
The influence of chronic kidney disease on intraoperative parathyroid hormone monitoring during parathyroidectomy for primary hyperparathyroidism has not been well-established. We hypothesize that chronic kidney disease influences intraoperative parathyroid hormone degradation kinetics during parathyroidectomy.
Source: Surgery - Category: Surgery Authors: Tags: American Association of Endocrine Surgeons Source Type: research
Conclusions Oral and maxillofacial manifestations of BTH and OF/RO are uncommon, but they can be associated with an important life-threatening scenario.
Source: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology - Category: ENT & OMF Source Type: research
The triad composed by α-Klotho, fibroblast growth factor-23, and its receptor are involved in the pathogenesis of chronic kidney disease–mineral and bone disorder. A disintegrin and metalloproteinase 17 (ADAM17) is a metalloproteinase causing the proteolytic shedding of α-Klotho from the cell membrane, and its role i n chronic kidney disease–mineral and bone disorder is not yet known. We studied the circulating levels of the above-mentioned mediators in patients with secondary hyperparathyroidism due to uremia, compared to control subjects, as well as in patients with primary hyperparathyroidism.
Source: Journal of Renal Nutrition - Category: Urology & Nephrology Authors: Tags: ICURT Proceedings Source Type: research
Parathyroid glands of young adults consist primarily of chief cells. However, with age or after excessive functional stress, another cell type increases progressively —the oxyphil cell. There is evidence for a chief-to-oxyphil cell transdifferentiation in chronic kidney disease. The latter may represent a defense mechanism, transforming the actively secreting chief cells to a less actively secreting cell type. However, even if this strategy is able to delay th e development of secondary hyperparathyroidism, it cannot prevent it.
Source: Kidney International - Category: Urology & Nephrology Authors: Tags: Commentary Source Type: research
In conclusion, etelcalcetide and paricalcitol similarly atte nuated progression of SHPT in an adenine rat model of CKD. However, etelcalcetide differentially prevented vascular calcification, at least in part, due to reductions in serum FGF23, calcium, and phosphorus levels.
Source: Calcified Tissue International - Category: Orthopaedics Source Type: research
Conclusion: A trephine biopsy helps us in understanding the skeletal symptoms of the CKD when the clinical and biochemical parameters are not conclusive. A biopsy in unexplained bone pain/fractures, unexplained hypercalcemia and elevated phosphate levels helps in guiding the proper management of the patient.
Source: Indian Journal of Hematology and Blood Transfusion - Category: Hematology Source Type: research
Conclusions Oral and maxillofacial manifestations of BTH and OF/RO are uncommon, but they can be associated with an important life threatening scenario.
Source: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology - Category: ENT & OMF Source Type: research
AbstractPurpose of the reviewThere is an increasing body of evidence that the trabecular bone score (TBS), a surrogate of bone microarchitecture extracted from spine DXA, could play an important role in the management of patients with osteoporosis or at risk of fracture. The current paper reviews this published body of scientific literature on TBS and answers the most relevant clinical questions.Recent findingsTBS has repeatedly been proven to be predictive of fragility fractures, current and future, and this is largely independent of BMD, CRF, and the FRAX, and when used in conjunction with any one of these measures, it c...
Source: Current Osteoporosis Reports - Category: Orthopaedics Source Type: research
Chronic kidney disease (CKD) and end-stage renal disease (ESRD) are associated with abnormalities in bone and mineral metabolism, known as CKD-bone mineral disorder. CKD and ESRD cause skeletal abnormalities characterized by hyperparathyroidism, mixed uremic osteodystrophy, osteomalacia, adynamic bone disease, and frequently enhanced vascular and ectopic calcification. Hyperparathyroidism and mixed uremic osteodystrophy are the most common manifestations due to phosphate retention, reduced concentrations of 1,25-dihydroxyvitamin D, intestinal calcium absorption, and negative calcium balance. Treatment with 1-hydroxylated v...
Source: Endocrinology and Metabolism Clinics of North America - Category: Endocrinology Authors: Source Type: research
More News: Chronic Kidney Disease | Drugs & Pharmacology | Food and Drug Administration (FDA) | Health | Hyperparathyroidism | Urology & Nephrology