Status:
COMPLETED
7 Day Continuous Parathyroid Hormone IV Infusion
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Osteoporosis
Bone Diseases, Endocrine
Eligibility:
All Genders
24-35 years
Phase:
EARLY_PHASE1
Brief Summary
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 administr...
Detailed Description
This study will expand upon earlier infusions studies that demonstrated: 1) There is a dose-related increase in 1,25 (OH)2 vitamin D in response to PTHrP and PTH over multiple days. 2) There is a mark...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00377312
Start Date
September 1 2006
End Date
December 1 2007
Last Update
March 22 2016
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213