Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Heart and Blood Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Kidney Diseases

Renal Insufficiency

Neoplasm Metastasis

Vascular Diseases

Hyperparathyroidism

Hyperparathyroidism, Secondary

Calcinosis

Vascular Calcification

Neoplastic Processes

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Bone Density Conservation Agents

Cinacalcet

Hormones

Calcium

Calcium, Dietary

Hormone Antagonists

Oral Cinacalcet treatment arm, 25mg daily to be administered and gradually step up as required to control iPTH between 2 - 9 times lab reference range, Maximum dose to be given is 100mg daily

Surgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm.

oral cinacalcet 25mg once daily as a start and up titrated by 25mg daily according to response in lowering PTH and maximum oral dose allowed is 100mg daily

Surgical total parathyroidectomy with forearm autografting will be performed

Surgical total parathyroidectomy with forearm autografting

Angela YM Wang, MD, PhD

This is a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of severe SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification and left ventricular mass index in endstage renal disease patients receiving peritoneal dialysis over 12 months. The change in arterial stiffening, left ventricular volume, aortic valve calcium score and bone mineral density, nutritional status and biochemical parameters, quality of life measures will be evaluated as secondary objectives of this study.

Patients with severe secondary hyperparathyroidism (SHPT) are frequently complicated with vascular calcification. There is some suggestion that subtotal parathyroidectomy may reduce or stabilize vascular calcium scores in dialysis patients. Experimental data suggests that SHPT plays an important role in mediating uraemic arterial disease and that parathyroidectomy largely prevented the development of calcification. Cinacalcet has emerged as a novel therapy for the treatment of SHPT and has been shown to reduce the need for surgical parathyroidectomy. However, their effects on vascular, cardiac, bone and nutrition status have not been evaluated and compared with parathyroidectomy.

Cinacalcet medical treatment versus total parathyroidectomy with forearm autografting surgical treatment

Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

Comparison of Medical Therapy (Oral Cinacalcet) Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Randomized Study

change in left ventricular volume and ejection fraction

Change in aortic valve and mitral valve calcium score

change in augmentation index and heart rate adjusted augmentation index

change in bone mineral density at forearm, spine and femur

Kidney Disease Outcome Quality Initiatives (KDOQI QOL domain scores)

Change in biochemical parameter Serum calcium and phosphorus

Change in biochemical parameter Parathyroid hormone

Change in biochemical parameter alkaline phosphatase

CHange in biochemical parameter serum albumin

change in systolic and diastolic blood pressure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients	NCT01447368	Kidney Failure Secondary Hyper... Vascular Diseas...	Cinacalcet Surgical total ...	18 Years - 75 Years	The University of Hong Kong
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients	NCT01447368	Kidney Failure Secondary Hyper... Vascular Diseas...	Cinacalcet Surgical total ...	18 Years - 75 Years	The University of Hong Kong

Spots Global Cancer Trial Database for surgical total parathyroidectomy with forearm autografting