Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Supportive care Active 24 to 35 NCI, Other PRO07040081 NIH Ro-DK 073039, NCT00580788

Trial Description

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.

Further Study Information

During this research the investigators administer PTHrP to healthy young volunteers in a controlled, continuous intravenous manner. As research subjects complete the week-long study without adverse effects, the dose of PThrP will be increased in later subjects. In the event of a significant adverse effect, immediate action will be taken to reverse it. The investigators want to estimate the effect of a sustainable level of mild hypercalcemia achieved by a week-long intravenous infusion of PTHrP has on vitamin D metabolism, markers of bone turnover and fractional excretion of calcium.

Eligibility Criteria

Inclusion Criteria:

• Healthy caucasian subjects of both sexes between the ages of 24-35 years, who are able to spend one week on the Clinical & Translational Research Center at UPMC Montefiore

Exclusion Criteria:

• Pregnancy

• Any cardiac, renal, pulmonary, endocrine, musculoskeletal, hepatic, hematological, malignant or rheumatologic diseases

• Body mass index great than 30

• Anemia

• Significant alcohol or drug abuse

• Baseline hypotension or hypertension

• Abnormal screening labs

• Use of certain chronic medications excluding oral contraceptives

• Receiving an investigational drug in the last 90 days

• Previously receiving PTH or PTHrP

• African-American race

Trial Contact Information

Trial Lead Organizations/Sponsors

UPMC Cancer Centers

Mara J Horwitz, MD

Principal Investigator

Mary Beth Tedesco, CRNP		Ph: 412-383-8704
		Email: tedesco@dom.pitt.edu

Linda Prebehalla, RN		Ph: 412-647-6470
		Email: lprebeh@pitt.edu

U.S.A.
Pennsylvania
	Pittsburgh
	UPMC Cancer Centers
		Mary Beth Tedesco, CRNP	Ph: 412-383-8704
			Email: tedesco@dom.pitt.edu
		Linda Prebehalla, RN	Ph: 412-647-6470
			Email: lprebeh@pitt.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00580788
Information obtained from ClinicalTrials.gov on October 06, 2008