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NCT00001277 · ClinicalTrials.gov registry record · Phase 2
Studies of Elevated Parathyroid Activity
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 1,553
- Enrollment target
NCT00001277: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00001277 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 1,553 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1068% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001277, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,553 participants
- Enrollment target
Study 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 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.
Primary Outcome
The purpose of this study is to understand the causes of primary hyperparathyroidism, to evaluate and improve methods for diagnosis and treatment, and to provide insight into the mechanisms of normal parathyroid function. Hereditary causes of primary hyperparathyroidism will be characterized. Patients were categorized as follows: 1. MEN1: Diagnosed by demonstration of a germline variant in MEN1 gene or one of the following: a) two of three primary MEN1 manifestations b) one primary MEN1 manifes
Interventions
- DRUG 68Ga-Dotatate
- DRUG 18F-DOPA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,553 participants |
| Start Date | 1993-12-15 |
| Est. Completion | 2020-12-23 |
| Phase | Phase 2 |
What the finished NCT00001277 record still lists
NCT00001277 is an interventional study that assigns participants to a tested intervention. Its 1,553 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1068% higher).
The record links to 0 conditions, and to 2 interventions - of which 68Ga-Dotatate is the first listed.
NCT00001277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001277 about?
NCT00001277 is a clinical study titled "Studies of Elevated Parathyroid Activity". 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 wi...
What is the current status of trial NCT00001277?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,553 participants. The study started on 1993-12-15. Estimated completion is 2020-12-23.
What interventions are being tested in trial NCT00001277?
The interventions under investigation include: 68Ga-Dotatate (DRUG), 18F-DOPA (DRUG).
Who is sponsoring clinical trial NCT00001277?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001277's enrollment target sits among peer trials
1,553 11th of 2000 higher than 1,990 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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