"PTHrP(1-36) IV Dose Escalation Study"
This is a single-blinded, one-treatment, combination dose escalation and pharmacokinetic study done in healthy volunteers. The investigators want to determine whether PTHrP(1-36) shares anabolic properties with the only currently approved anabolic agent, parathyroid hormone or PTH(1-34), which stimulates both osteoblastic bone resorption and formation. In a previous study done by the investigators, postmenopausal osteoporotic women on estrogen received 6.56 mcg/kg PTHrP(1-36) subcutaneously for three months daily. They experiences a 4.7% increase in bone mineral density (BMD) of the lumbar spine when compared with those taking placebo. They also displayed an increase in serum osteocalcin, a marker of bone formation, with no change in several markers of bone resorption. It is believed that the rapid absorption and clearance of PTHrP(1-36) likely plays a central role in its anabolic effect In order to further assess absorption, we are combining both pharmacokinetic and dose escalation methods for studying intravenous PTHrP given via a one-time bolus injection. The purpose is to define the maximum safe dose and measure the pharmacokinetic parameters of a single intravenous dose of Parathyroid Hormone-related Protein (1-36)[PTHrP(1-36)]. The results will be useful in determining future treatment options for osteoporosis.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||"Determining the Maximum Tolerable Dose and Pharmacokinetic Parameters of Intravenous PTHrP(1-36)"|
- The absence of any dose limiting toxicity criteria [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
- Measurement of vitamin D levels, markers of bone metabolism and fractional excretion of calcium measurements [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Experimental: PTHrP group
Subjects receiving PTHrP in varying doses.
Drug: Parathyroid Hormone-related Protein
Parathyroid Hormone-related Protein in doses started at a 4 microgram single bolus intravenous dose. Dose will be increase to a maximum of 400 micrograms or until a dose limiting toxicity occurs at a lower dose.
Other Name: PTHrP(1-36)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00177411
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Mara J. Horwitz, MD||University of Pittsburgh|