7 Day Continuous Parathyroid Hormone IV Infusion

Completed · Early Phase 1

Conditions studied: Osteoporosis, Bone Diseases, Endocrine, Hyperparathyroidism

In brief

Study consists of an eight day inpatient visit on the General Clinical Research Center. The investigators' specific aims are to: 1. To define the maximum safe dose of a seven day continuous administration of parathyroid hormone \[PTH(1-34)\] in healthy human volunteers. 2. To estimate the effect of a seven day continuous administration of parathyroid Hormone (PTH) in escalating doses on vitamin D metabolism, markers of bone turnover and fractional excretion of urine.

Key facts

Study ID

NCT00377312

Run by

University of Pittsburgh

People needed

11

Starts

2006-09-01

Expected to finish

2007-12-01

Last updated by the study team

2016-03-22

Who can join

Age: 24 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Caucasian, Hispanic or Asian subjects
• Males and Females
• Non-smoker
• Ages 24 - 35 years old
• Subjects will be recruited either from the employee pool of the University of Pittsburgh or the University of Pittsburgh Medical Center (UPMC), or the general population living in the vicinity.
• Participation in this study by an employee or a potential employee at the University of Pittsburgh or UPMC has no effect on their employment or potential employment.
• Participants in the study will be required to discontinue all vitamins and health food supplements two weeks prior to the study.

You may not qualify if…

• Cardiac, hypertensive, vascular, renal (serum creatinine of >1.5), pulmonary, endocrine, musculoskeletal, hepatic, hematologic or malignant or rheumatologic disease
• Body Mass Index (BMI) > 30,
• Anemia (hematocrit less than 36% in women, less than 40% in men),
• Pregnancy (all women will have a urine pregnancy test performed immediately before starting the study and must not be pregnant)
• Significant alcohol or drug abuse or
• Baseline hypotension (systolic blood pressure less than 90 mm/Hg).
• Subjects will be excluded for abnormal levels of any of the screening labs including: ionized and total serum calcium, phosphorus, creatinine, albumin, 25-hydroxyvitamin D, and PTH. Pregnancy
• Subjects taking any chronic medications except oral contraceptives and stable doses of thyroid hormone, or those who have received any investigational drug in past 90 days will be excluded from the study.
• Subjects may not participate in this study more than once.
• Any subject who has previously received PTH or PTHrP, a related peptide, may not participate in this study.
• Minority Inclusion/Exclusion Statement: We will not include African-Americans because this group has been demonstrated by a number of investigators to display resistance to PTH, and may create wider statistical variation and a need for larger numbers of study subjects per group.

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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