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NCT00001304 · ClinicalTrials.gov registry record · Phase 2
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
A Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT00001304 is a Phase 2 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 27 participants.
The verdict
NCT00001304, a Phase 2 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, PTH. The primary goals of this study are to (1) provide long-term PTH therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.
Interventions
- DRUG Synthetic Human Parathyroid Hormone 1-34
- DRUG Calcitriol & Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 1991-10 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001304
The ClinicalTrials.gov registry entry for NCT00001304 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Synthetic Human Parathyroid Hormone 1-34 is the first listed.
NCT00001304 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001304 about?
NCT00001304 is a clinical study titled "Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34". This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to co...
What is the current status of trial NCT00001304?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 1991-10. Estimated completion is 2014-04.
What interventions are being tested in trial NCT00001304?
The interventions under investigation include: Synthetic Human Parathyroid Hormone 1-34 (DRUG), Calcitriol & Calcium (DRUG).
Who is sponsoring clinical trial NCT00001304?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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