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NCT00395538 · ClinicalTrials.gov registry record · Phase 3
Effects of PTH Replacement on Bone in Hypoparathyroidism
A Phase 3 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Terminated
- Registry status
- Phase 3
- Development phase
- 46
- Enrollment target
NCT00395538 is a Phase 3 study that was terminated before completion, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 46 participants.
The verdict
NCT00395538, a Phase 3 study, was terminated before completion, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 46 participants
- Enrollment target
Study Summary
Hypoparathyroidism is a rare condition associated with a low level of parathyroid hormone (PTH) in the blood. Hypoparathyroidism can be genetic and show up in childhood, or it can occur later in life. If it occurs later, it is usually due to damage or removal of the parathyroid glands during neck surgery. PTH helps control the amount of calcium in blood, kidneys, and bones. Low levels of calcium in the blood can cause a person to feel sick. It can cause cramping or tingling in the hands, feet, or other parts of the body. A very low blood calcium can cause fainting or seizures. The standard treatment for hypoparathyroidism is a form of vitamin D (calcitriol) and calcium supplements. Keeping normal blood levels of calcium can be difficult. Sometimes there is too much calcium in the urine even if the calcium levels in the blood are low. High calcium in the kidneys and urine can cause problems such as calcium deposits in the kidney (nephrocalcinosis) or kidney stones. High levels of calcium in the kidney may keep the kidney from functioning normally. Treatment with PTH will replace the hormone you are missing. Your disease may be better controlled on PTH than on calcium and calcitriol. Researchers at the NIH have conducted prior studies to establish synthetic human parathyroid hormone 1-34 (HPTH) as a treatment for hypoparathyroidism. Other studies have shown that PTH may improve calcium levels in blood and urine. The primary purpose of this research study is to evaluate the effects of synthetic human parathyroid hormone 1-34 (HPTH) replacement therapy on bone in adults and teenagers with hypoparathyroidism. The study takes 5 (Omega) years to complete and requires 12 inpatient visits to the National Institutes of Health Clinical Center in Bethesda, MD. The first visit will help the study team decide whether you are eligible. This visit will last 2 to 3 days. After taking calcium and calcitriol for 1 - 7 months you will return to the NIH Clinical Center for the baseli
Interventions
- DRUG PTH 1-34
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2006-10-30 |
| Est. Completion | 2017-10-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00395538
The ClinicalTrials.gov registry entry for NCT00395538 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PTH 1-34 is the first listed.
NCT00395538 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00395538 about?
NCT00395538 is a clinical study titled "Effects of PTH Replacement on Bone in Hypoparathyroidism". Hypoparathyroidism is a rare condition associated with a low level of parathyroid hormone (PTH) in the blood. Hypoparathyroidism can be genetic and show up in childhood, or it can occur later in life. If it occurs later, it is usually due to damage or removal of the parathyroid glands during neck su...
What is the current status of trial NCT00395538?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 46 participants. The study started on 2006-10-30. Estimated completion is 2017-10-04.
What interventions are being tested in trial NCT00395538?
The interventions under investigation include: PTH 1-34 (DRUG).
Who is sponsoring clinical trial NCT00395538?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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