"PTHrP(1-36) IV Dose Escalation Study"
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|ClinicalTrials.gov Identifier: NCT00177411|
Recruitment Status : Withdrawn (Protocol design was changed so it no longer fit the description of this study.)
First Posted : September 15, 2005
Last Update Posted : September 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: Parathyroid Hormone-related Protein||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||"Determining the Maximum Tolerable Dose and Pharmacokinetic Parameters of Intravenous PTHrP(1-36)"|
|Study Start Date :||July 2005|
|Primary Completion Date :||July 2007|
|Study Completion Date :||July 2007|
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)
- The absence of any dose limiting toxicity criteria [ Time Frame: 6 hours ]
- Measurement of vitamin D levels, markers of bone metabolism and fractional excretion of calcium measurements [ Time Frame: 6 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177411
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Mara J. Horwitz, MD||University of Pittsburgh|