CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 14 enrolled
Drug / intervention
PTHrP (1-36)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00580788
NCT00580788Early Ph 1Completed
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Determining the Maximal Safe Dose of a Continuous Infusion of Parathyroid Hormone-related Protein(1-36): Effects on Bone Formation

University of Pittsburgh·interventional·Posted Dec 27, 2007·Updated Feb 11, 2016

In Brief

A Early Phase 1 clinical trial evaluating PTHrP (1-36) for Osteoporosis and 2 related conditions. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Humoral Hypercalcemia of Malignancy, Hyperparathyroidism
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Early Ph 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 27, 2007
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.5 years ago

Interventions

PTHrP (1-36)drug

IND # 49,175