7 Day Continuous Parathyroid Hormone IV Infusion
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Purpose
Study consists of an eight day inpatient visit on the General Clinical Research Center. The investigators' specific aims are to:
- To define the maximum safe dose of a seven day continuous administration of parathyroid hormone [PTH(1-34)] in healthy human volunteers.
- To estimate the effect of a seven day continuous administration of PTH in escalating doses on vitamin D metabolism, markers of bone turnover and fractional excretion of urine.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis Bone Diseases, Endocrine Hyperparathyroidism |
Drug: parathyroid hormone (1-34) |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Determining the Maximal Safe Dose of a Continuous Infusion of Parathyroid Hormone(1-34): Effects on Bone Formation |
- Blood collections for safety measurements including serum ionized and total calcium, phosphorus and creatinine [ Time Frame: one week ] [ Designated as safety issue: Yes ]
- Blood collections analyzed for measurements of PTH(1-34), PTH(1-84), 25-hydroxy Vitamin D, 1,25 (OH)2 vitamin D and markers of bone turnover. [ Time Frame: one week ] [ Designated as safety issue: No ]
| Enrollment: | 19 |
| Study Start Date: | September 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PTH dosing group
Subjects receive PTH(1-34) starting with doses of 2 pmols/kg/hr for one week. Subsequent dosing groups are determined by the response to PTH doses.
|
Drug: parathyroid hormone (1-34)
2 pmols/kg/hr and greater
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 24 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: Healthy Caucasian, Hispanic or Asian subjects of both sexes who are non-smokers and between the ages of 24 - 35 years old will be included in the study. Subjects will be recruited either from the employee pool of the University of Pittsburgh or 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. All women will have a urine pregnancy test performed immediately before starting the study and must not be pregnant.
Exclusion Criteria:Exclusion Criteria: Subjects with cardiac, hypertensive, vascular, renal (serum creatinine of >1.5), pulmonary, endocrine, musculo-skeletal, hepatic, hematologic or malignant or rheumatologic disease will be excluded from the study. Additional exclusion criteria will include: a Body Mass Index (BMI) > 30, anemia (hematocrit less than 36% in women, less than 40% in men), pregnancy, or 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. Also, 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. In addition, 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.
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh,, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Mara J. Horwitz, MD | University of Pittsburgh |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mara Horwitz, Associate Professor of Medicne, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00377312 History of Changes |
| Other Study ID Numbers: | 0606127, R01DK073039 |
| Study First Received: | September 14, 2006 |
| Last Updated: | July 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pittsburgh:
|
Endocrine System Diseases MusculoSkeletal System Disease Hormone Postmenopausal Women Physiologic Properties |
Additional relevant MeSH terms:
|
Bone Diseases Bone Diseases, Endocrine Bone Diseases, Metabolic Endocrine System Diseases Hyperparathyroidism Osteoporosis |
Musculoskeletal Diseases Parathyroid Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013