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NCT00743782 · ClinicalTrials.gov registry record · Phase 2
Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00743782: Completed Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00743782 is a Phase 2 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00743782, a Phase 2 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This randomized crossover study will evaluate the safety, efficacy, and pharmacodynamics of synthetic human PTH 1-34 (PTH) delivered by an insulin pump (omnipod) compared with twice- daily subcutaneous injections. We predict pump delivery of PTH will simultaneously normalize blood and urine mineral levels with minimal or no fluctuations throughout the day, thus resulting in a more physiologic pharmacodynamic profile because this method of delivery mimics normal parathyroid gland function. Furthermore, we hypothesize that pump therapy will require lower PTH doses and will normalize markers of bone turnover. We anticipate the improved metabolic control when PTH is delivered by pump will be evident both in adults with surgically induced hypoparathyroidism and in children with more severe forms of hypoparathyroidism where there is an unmet need for improved therapy.
Primary Outcome
Mean fasting serum calcium level at the end of week 13. After 13 weeks of PTH 1-34 administration, participants were admitted for five to seven days and fasting blood sample was collected each morning (6-8 am) for three days. Mean value for the three days was calculated.
Interventions
- DRUG Synthetic Human Parathyroid Hormone 1-34 pump
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-08-22 |
| Est. Completion | 2014-04-07 |
| Phase | Phase 2 |
What the finished NCT00743782 record still lists
NCT00743782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Synthetic Human Parathyroid Hormone 1-34 pump is the first listed.
NCT00743782 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00743782 about?
NCT00743782 is a clinical study titled "Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism". This randomized crossover study will evaluate the safety, efficacy, and pharmacodynamics of synthetic human PTH 1-34 (PTH) delivered by an insulin pump (omnipod) compared with twice- daily subcutaneous injections. We predict pump delivery of PTH will simultaneously normalize blood and urine mineral ...
What is the current status of trial NCT00743782?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2008-08-22. Estimated completion is 2014-04-07.
What interventions are being tested in trial NCT00743782?
The interventions under investigation include: Synthetic Human Parathyroid Hormone 1-34 pump (DRUG).
Who is sponsoring clinical trial NCT00743782?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00743782's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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