Studies of Elevated Parathyroid Activity

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001277
First received: November 3, 1999
Last updated: March 14, 2014
Last verified: January 2014
  Purpose

Patients whose parathyroid activity is elevated above normal are referred to as having hyperparathyroidism. This study will help researchers better understand the causes of hyperthyroidism and to evaluate and improve methods for diagnosis and treatment.

In this study, 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.


Condition
Hyperparathyroidism
Hypocalcemia
Hypoparathyroidism
Parathyroid Neoplasm

Study Type: Observational
Official Title: Studies of Hyperparathyroidism and Related Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 99999999
Study Start Date: March 1991
Detailed Description:

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 and parathyroid hormone in serum. Patients with moderately to highly 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients (male or female any age) with known or suspected primary hyperparathyroidism or a related disorder (such as familial multiple endocrine neoplasia type 1 [MEN1]) will be evaluated.

The vast majority of patients will be greater than age 18.

In the rare occasion where special resources might be appropriate (uremic patient, young child), the availability of special resources would be confirmed prior to admission.

EXCLUSION CRITERIA:

There are no absolute exclusions.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001277

Contacts
Contact: Stephen J Marx, M.D. (301) 496-5051 marxs@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
United Services University of Health Services Recruiting
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen J Marx, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001277     History of Changes
Other Study ID Numbers: 910085, 91-DK-0085
Study First Received: November 3, 1999
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Parathyroid
Calcium
Vitamin D

Additional relevant MeSH terms:
Hypocalcemia
Hyperparathyroidism
Hypoparathyroidism
Parathyroid Neoplasms
Calcium Metabolism Disorders
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Metabolic Diseases
Neoplasms
Neoplasms by Site
Parathyroid Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on October 20, 2014