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NCT00377312 · ClinicalTrials.gov registry record · Early Phase 1
7 Day Continuous Parathyroid Hormone IV Infusion
A Early Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT00377312: Completed Early Phase 1 study, sponsored by University of Pittsburgh.
NCT00377312 is a Early Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 11 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00377312, a Early Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Study consists of an eight day inpatient visit on the General Clinical Research Center. The investigators' specific aims are to: 1. To define the maximum safe dose of a seven day continuous administration of parathyroid hormone \[PTH(1-34)\] in healthy human volunteers. 2. To estimate the effect of a seven day continuous administration of parathyroid Hormone (PTH) in escalating doses on vitamin D metabolism, markers of bone turnover and fractional excretion of urine.
Primary Outcome
DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall \>30 mm/hg), tachycardia (pulse \> 120), hypertension (systolic BP \>160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous \< 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness,
Interventions
- DRUG Parathyroid Hormone (1-34)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-12 |
| Phase | Early Phase 1 |
What the finished NCT00377312 record still lists
NCT00377312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Parathyroid Hormone (1-34) is the first listed.
NCT00377312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00377312 about?
NCT00377312 is a clinical study titled "7 Day Continuous Parathyroid Hormone IV Infusion". Study consists of an eight day inpatient visit on the General Clinical Research Center. The investigators' specific aims are to: 1. To define the maximum safe dose of a seven day continuous administration of parathyroid hormone \[PTH(1-34)\] in healthy human volunteers. 2. To estimate the effect of...
What is the current status of trial NCT00377312?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2006-09. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00377312?
The interventions under investigation include: Parathyroid Hormone (1-34) (DRUG).
Who is sponsoring clinical trial NCT00377312?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00377312's enrollment target sits among peer trials
11 1601st of 2000 higher than 373 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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