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NCT00580788 · ClinicalTrials.gov registry record · Early Phase 1
One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study
A Early Phase 1 study of Osteoporosis and Hyperparathyroidism, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT00580788 is a Early Phase 1 study of Osteoporosis and Hyperparathyroidism that has completed, run by University of Pittsburgh. The registered enrollment target is 14 participants, below the 1,546-participant average among 84 other Osteoporosis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00580788, a Early Phase 1 study of Osteoporosis and Hyperparathyroidism, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrp on markers of bone turnover, and plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.
Conditions Studied
Interventions
- DRUG PTHrP (1-36)
Study Locations (1)
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00580788
The ClinicalTrials.gov registry entry for NCT00580788 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,546-participant average among 84 other Osteoporosis trials with a reported enrollment target (99% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Osteoporosis appearing as the primary indexed condition, and to 1 intervention - of which PTHrP (1-36) is the first listed.
NCT00580788 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00580788 about?
NCT00580788 is a clinical study titled "One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study". This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and progressive suppression of bone f...
What is the current status of trial NCT00580788?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 14 participants. The study started on 2008-01. Estimated completion is 2009-12.
What conditions does trial NCT00580788 study?
This clinical trial studies the following conditions: Osteoporosis, Hyperparathyroidism, Humoral Hypercalcemia of Malignancy.
What interventions are being tested in trial NCT00580788?
The interventions under investigation include: PTHrP (1-36) (DRUG).
Who is sponsoring clinical trial NCT00580788?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00580788 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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