7 Day Continuous Parathyroid Hormone IV Infusion

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mara Horwitz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00377312
First received: September 14, 2006
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Blood collections for safety measurements including serum ionized and total calcium, phosphorus and creatinine [ Time Frame: one week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377312

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh,, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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
Endocrine System Diseases
Hyperparathyroidism
Osteoporosis
Musculoskeletal Diseases
Parathyroid Diseases
Bone Diseases, Metabolic
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014