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Sponsors and Collaborators: |
University of Pittsburgh National Institutes of Health (NIH) |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00377312 |
Study consists of an eight day inpatient visit on the General Clinical Research Center. The investigators' specific aims are to:
Condition | Intervention | Phase |
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Osteoporosis Bone Diseases, Endocrine Hyperparathyroidism |
Drug: parathyroid hormone (1-34) |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Subject), Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Determining the Maximal Safe Dose of a Continuous Infusion of Parathyroid Hormone(1-34): Effects on Bone Formation |
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 |
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PTH dosing group: Experimental
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.
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Drug: parathyroid hormone (1-34)
2 pmols/kg/hr and greater
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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.
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh,, Pennsylvania, United States, 15213 |
Principal Investigator: | Mara J. Horwitz, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh School of Medicine ( Mara Horwitz, MD ) |
Study ID Numbers: | 0606127, NIH RO-DK 073039 |
Study First Received: | September 14, 2006 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00377312 |
Health Authority: | United States: Food and Drug Administration |
Endocrine System Diseases MusculoSkeletal System Disease Hormone Postmenopausal Women Physiologic Properties |
Bone Diseases, Endocrine Parathyroid Diseases Musculoskeletal Diseases Hyperparathyroidism Endocrine System Diseases |
Osteoporosis Bone Diseases, Metabolic Endocrinopathy Bone Diseases |