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NCT01199614 · ClinicalTrials.gov registry record · Phase 3
HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism
A Phase 3 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT01199614 is a Phase 3 study that has completed, run by Columbia University. The registered enrollment target is 62 participants.
The verdict
NCT01199614, a Phase 3 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study Summary
This is an open-label study of PTH(1-84) treatment that seeks: 1. To determine the actions of PTH(1-84) to provide long term control of serum calcium and urinary calcium excretion with use of standard amounts of calcium and vitamin D supplementation. 2. To determine the extent to which PTH(1-84) improves quality-of-life on long-term basis. 3. To establish the safety of PTH(1-84) when administered for up to 12 years. 4. To attempt to quantify improvements in the typical signs/symptoms of hypoparathyroidism post PTH administration. There will be one visit conducted every six months in the study offices of the principal investigator, Dr. John Bilezikian. In addition to these visits, there will be, for new patients who have not used PTH (1-84) before, a Screening Visit four weeks prior to the baseline visit for the purpose of performing screening labs as well as a Pre-Baseline Local Quest Lab performed to ensure stability prior to Baseline.
Interventions
- DRUG open-label PTH(1-84)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2009-12 |
| Est. Completion | 2017-06-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01199614
The ClinicalTrials.gov registry entry for NCT01199614 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which open-label PTH(1-84) is the first listed.
NCT01199614 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01199614 about?
NCT01199614 is a clinical study titled "HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism". This is an open-label study of PTH(1-84) treatment that seeks: 1. To determine the actions of PTH(1-84) to provide long term control of serum calcium and urinary calcium excretion with use of standard amounts of calcium and vitamin D supplementation. 2. To determine the extent to which PTH(1-84) im...
What is the current status of trial NCT01199614?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2009-12. Estimated completion is 2017-06-26.
What interventions are being tested in trial NCT01199614?
The interventions under investigation include: open-label PTH(1-84) (DRUG).
Who is sponsoring clinical trial NCT01199614?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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