Status:
COMPLETED
Studies of Elevated Parathyroid Activity
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hyperparathyroidism
Hypercalcemia
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief Summary
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 hyperp...
Detailed Description
Observational: Patients with confirmed or suspected primary hyperparathyroidism or complications therefrom (such as postoperative hypoparathyroidism) will be admitted for diagnosis and treatment. The ...
Eligibility Criteria
INCLUSION CRITERIA:
- Patients who have genetically confirmed MEN1 or clinical criteria of MEN1.
- For females: Negative urine pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy
EXCLUSION CRITERIA:
- Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure or congestive cardiac failure
- Patients unable or unwilling to give informed consent
- Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 68Ga-DOTATATE in pregnancy are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68Ga-DOTATATE in the mother, women who are breastfeeding are also excluded from this study
- Patients that have recognized concurrent active infection
- Patients with known hypersensitivity to carbidopa, or who are concurrently taking a nonselective monoamine oxidase (MAO) inhibitor..
Key Trial Info
Start Date :
December 15 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2020
Estimated Enrollment :
1553 Patients enrolled
Trial Details
Trial ID
NCT00001277
Start Date
December 15 1993
End Date
December 23 2020
Last Update
June 7 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892