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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: Completed Early Phase 1 study of Osteoporosis and Hyperparathyroidism, sponsored by University of Pittsburgh.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

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,

Conditions Studied

Osteoporosis Hyperparathyroidism Humoral Hypercalcemia of Malignancy

Interventions

  • DRUG PTHrP (1-36)

Study Locations (1)

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2008-01
Est. Completion 2009-12
Phase Early Phase 1
University of Pittsburgh

1,238 total trials

What the finished NCT00580788 record still lists

NCT00580788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,546-participant average among 84 other Osteoporosis trials with a reported enrollment target (99% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Osteoporosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00580788's enrollment target sits among peer trials

14 79th of 84 higher than 6 of 84 other Osteoporosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Osteoporosis 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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Related registry views

Source: ClinicalTrials.gov NCT00580788, the US trial registry maintained by the National Library of Medicine. NCT00580788 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.