Hyperparathyroidism Clinical Trial
Official title:
Studies of Hyperparathyroidism and Related Disorders
Observational Phase: Patients whose parathyroid activity is elevated above normal are referred to as having hyperparathyroidism. This study will help researchers better understand the causes of hyperparathyroidism and to evaluate and improve methods for diagnosis and treatment. Patients diagnosed with or suspected of having hyperparathyroidism will be selected to participate. In addition, patients with related conditions, such as parathyroid tumors, will also be selected. Subjects will be asked to provide blood and urine for testing to confirm their condition. They will then be surgically treated by removal of the parathyroid gland(s) (parathyroidectomy). Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact location of the tumor as well as the tumor's activity. The tests may include; ultrasounds, nuclear scanning, CT scans, MRI, and specialized blood testing. Sometimes parathyroidectomy leads to hypoparathyroidism. Options for treating the patients after the surgical procedure will also be addressed. Calcium and Vitamin D supplements are typically the mainstay of post parathyroidectomy therapy. Other potential treatments include transplanting the parathyroid gland(s) to other areas of the body. Clinical Trial: An imaging substudy was added to this protocol in 2018. Patients with multiple endocrine neoplasia type 1 (MEN1) will have 68Gallium-Dotatate Positron Emission Tomography (PET) - Computed Tomography (CT), 18F-DOPA PET/CT, MRI, and CT scans and the number of lesions detected by each of these types of scans will be compared.
Observational: Patients with confirmed or suspected primary hyperparathyroidism or complications therefrom (such as postoperative hypoparathyroidism) will be admitted for diagnosis and treatment. The principal diagnostic components are calcium in serum and urine, parathyroid hormone in serum, and mutation tests on germline or tumor DNA. Patients with moderate to severe primary hyperparathyroidism will be treated. Treatment will be mainly by parathyroidectomy. Other options are medications or no intervention. Patients with a hyperparathyroid syndrome may be managed for their extraparathyroid features. Preoperative testing to localize parathyroid neoplasm(s) will be used usually and with more extended methods in cases with prior neck surgery. Preoperative tumor localization tests will be selected according to clinical indications from the following: ultrasound, technetium-thallium scan, computerized tomography, magnetic resonance imaging, fine needle aspiration for parathyroid hormone assay, selective arteriogram, selective venous catheterization for parathyroid hormone assay. Options for management of postoperative hypocalcemia include calcium, vitamin D analogs, parathyroid autografts and synthetic parathyroid hormone. Research specimens may consist of blood or tumors. Clinical Trial: An imaging substudy was added to this protocol in 2018. Patients with MEN1 will have 68Ga-Dotatate PET/CT, 18F-DOPA PET/CT, MRI, and CT scans and the number of lesions detected by each of these types of scans will be compared. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00377312 -
7 Day Continuous Parathyroid Hormone IV Infusion
|
Phase 0 | |
Completed |
NCT00379899 -
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
|
Phase 4 | |
Completed |
NCT04040946 -
Trial Comparing 2 Diagnostic Strategies for Preoperative Localization of Parathyroid Adenoma in Primary Hyperparathyroidism:TEMP / CT With Tc99m-sestaMIBI or PET / CT With F18-choline in First Intention
|
Phase 3 | |
Recruiting |
NCT03053999 -
Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)
|
||
Withdrawn |
NCT02711059 -
Insulin Resistance in Primary Hyperparathyroidism
|
N/A | |
Completed |
NCT01691781 -
The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study
|
N/A | |
Completed |
NCT00538720 -
Effects of Vitamin D Replacement in Patients With Primary Hyperparathyroidism (PHPT)
|
Phase 1 | |
Completed |
NCT00887666 -
Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure
|
N/A | |
Terminated |
NCT03044600 -
Gene Expression in Hyperparathyroidism
|
||
Completed |
NCT03747029 -
Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
|
||
Completed |
NCT01872429 -
Short- and Long-Term Impact of Subtotal Parathyroidectomy on the Achievement of Bone and Mineral Parameters Recommended by Clinical Practice Guidelines in Dialysis Patients
|
N/A | |
Completed |
NCT00800358 -
Safety and Efficacy Study of Paricalcitol Versus Calcitriol in the Treatment of Secondary Hyperparathyroidism
|
N/A | |
Recruiting |
NCT00169806 -
Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
|
N/A | |
Completed |
NCT03968510 -
Swalqol in Primary Hyperparathyroidism
|
||
Completed |
NCT00501215 -
Effect of Parathyroidectomy on Sleep
|
N/A | |
Completed |
NCT02591160 -
Optimal HCTZ Cessation for Diagnosis of Hyperparathyroidism
|
N/A | |
Recruiting |
NCT05299632 -
F-18 PSMA for Localization of Parathyroid Adenoma
|
||
Recruiting |
NCT02986607 -
Corticosteroid Rhythms in Hypoparathyroid Patients
|
Early Phase 1 | |
Completed |
NCT02432599 -
Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas
|
Phase 2 | |
Completed |
NCT02524041 -
Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism
|
N/A |