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Studies of Elevated Parathyroid Activity

This study is currently recruiting participants.
Study NCT00001277.   Last updated on July 18, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  Studies of Elevated Parathyroid Activity
Official Title  Studies of Hyperparathyroidism and Related Disorders
Brief Summary

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.

Detailed Description

Patients with confirmed or suspected primary hyperparathyroidism or complications therefrom (such as postoperative hypoparathyroidism) will be admitted for diagnosis and treatment. Patients with moderately severe primary hyperparathyroidism will be treated. The principal diagnostic components are calcium in serum and urine and parathyroid hormone in serum. Treatment will be mainly by parathyroidectomy.

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, arteriogram, selective venous catheterization for parathyroid hormone assay. Options for management of postoperative hypocalcemia include calcium, vitamin D preparations, parathyroid autografts and synthetic parathyroid hormone. Research specimens may consist of blood or tumors.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Hyperparathyroidism
Hypocalcemia
Hypoparathyroidism
Parathyroid Neoplasm
Intervention 
MEDLINE PMIDs 9103196,   8523102,   7916660
Links NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment 
Start Date  March 1991
Completion Date
Eligibility 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 [FMEN1]) 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.

Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Contact: Patient Recruitment and Public Liaison Office     (800) 411-1222     prpl@mail.cc.nih.gov    
Contact: TTY     1-866-411-1010        
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001277
Organization ID 910085
Secondary IDs †† 91-DK-0085
Study Sponsor  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date January 2008
First Received Date  November 3, 1999
Last Updated Date July 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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