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One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study

NCT00580788 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-02-11

Study results available
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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

  • Osteoporosis
  • Humoral Hypercalcemia of Malignancy
  • Hyperparathyroidism

Interventions

DRUG

PTHrP (1-36)

IND # 49,175

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Mara J Horwitz, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00580788 on ClinicalTrials.gov