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

NCT ID: NCT00580788

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-12-31

Brief 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.

Detailed Description

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.

Conditions

Osteoporosis; Humoral Hypercalcemia of Malignancy; Hyperparathyroidism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

PTHrP(1-36) 2 pmol/kg/hr

PTHrP(1-36) at 2 picomoles/kg/hr for one week.

Group Type: EXPERIMENTAL

PTHrP (1-36)

Intervention Type: DRUG

IND # 49,175

PTHrP (1-36) 4 pmol/kg/hr

PTHrP(1-36) at 4 picomoles/kg/hr for one week.

Group Type: EXPERIMENTAL

PTHrP (1-36)

Intervention Type: DRUG

IND # 49,175

PTHrP(1-36) 5 pmol/kg/hr

PTHrP(1-36) at 5 picomoles/kg/hr for one week.

Group Type: EXPERIMENTAL

PTHrP (1-36)

Intervention Type: DRUG

IND # 49,175

PTHrP(1-36) 6 pmol/kg/hr

PTHrP(1-36) at 6 picomoles/kg/hr for one week.

Group Type: EXPERIMENTAL

PTHrP (1-36)

Intervention Type: DRUG

IND # 49,175

Interventions

PTHrP (1-36)

IND # 49,175

Intervention Type: DRUG

Other Intervention Names

Parathyroid Hormone-related Protein (1-36)

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 the University of Pittsburgh Medical Center (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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Mara Horwitz

Associate Professor of Medicne

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mara J Horwitz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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Other Identifiers

R01DK073039

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO07040081

Identifier Type: -

Identifier Source: org_study_id