Determining the Maximal Safe Dose of a Continuous Infusion of Parathyroid Hormone-related Protein(1-36): Effects on Bone Formation
During this research the investigators administer PTHrP to healthy young volunteers in a
controlled, continuous intravenous manner. As research subjects complete the week-long
study without adverse effects, the dose of PThrP will be increased in later subjects. In
the event of a significant adverse effect, immediate action will be taken to reverse it.
The investigators want to estimate the effect of a sustainable level of mild hypercalcemia
achieved by a week-long intravenous infusion of PTHrP has on vitamin D metabolism, markers
of bone turnover and fractional excretion of calcium.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
The absence of any dose limiting toxicity (DLT) criteria consisting of one major criteria or two minor criteria.
Mara J Horwitz, MD
University of Pittsburgh
United States: Food and Drug Administration
|University of Pittsburgh Medical Center||Pittsburgh, Pennsylvania 15213|