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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: Completed Phase 3 study, sponsored by Columbia University.
NCT01199614 is a Phase 3 study that has completed, run by Columbia University. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Serum and urinary calcium levels maintained by change in requirements for calcium supplementation.
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 |
What the finished NCT01199614 record still lists
NCT01199614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which open-label PTH(1-84) is the first listed.
NCT01199614 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01199614's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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