"PTHrP(1-36) IV Dose Escalation Study"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (Protocol design was changed so it no longer fit the description of this study.)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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mara Horwitz, University of Pittsburgh

Brief Summary:
This is a single-blinded, one-treatment, combination dose escalation and pharmacokinetic study done in healthy volunteers. The investigators want to determine whether Parathyroid Hormone related Protein (1-36) [PTHrP(1-36)] shares anabolic properties with the only currently approved anabolic agent, parathyroid hormone(1-34) [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.

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
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: "Determining the Maximum Tolerable Dose and Pharmacokinetic Parameters of Intravenous PTHrP(1-36)"
Study Start Date : July 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. The absence of any dose limiting toxicity criteria [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Measurement of vitamin D levels, markers of bone metabolism and fractional excretion of calcium measurements [ Time Frame: 6 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Healthy Caucasian subjects of both sexes between the ages of 24-35 years -

Exclusion Criteria:

Pregnancy Subjects with cardiac, hypertension, vascular, renal, pulmonary, endocrine, musculoskeletal, hepatic hematologic or malignant or rheumatologic disease.

Body Mass Index greater than 30 anemia (hematocrit less than 36% in women, less than 40% in men) significant alcohol or drug abuse, baseline hypotension (systolic blood pressure less than 90 mm/HG) baseline hypertension (systolic BP greater than 140 mmHg or diastolic BP greater than 90 mmHg Abnormal screening labs including: ionized and total serum calcium, phosphorus, creatinine, albumin, 25-hydroxyvitamin D, and PTH.

Subjects taking any chronic medication except oral contraceptives Those who have received an investigational drug in the past 90 days Any subject who has previously received either PTH or PTHrP African Americans and other ethnic minorities will be excluded since it is well documented that osteoporosis is far more common in Caucasians than in African-Americans, and there are clear quantitative differences in bone density and sensitivity to parathyroid hormone between African-Americans and Caucasians. -

Information from the National Library of Medicine

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 identifier (NCT number): NCT00177411

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Mara J. Horwitz, MD University of Pittsburgh

Additional Information:

Responsible Party: Mara Horwitz, Associate Professor of Medicne, University of Pittsburgh Identifier: NCT00177411     History of Changes
Other Study ID Numbers: IRB # 0507001
R01DK051081 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Mara Horwitz, University of Pittsburgh:
Endocrine System Diseases
MusculoSkeletal System Diseases
Postmenopausal Women

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs