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

This study has been withdrawn prior to enrollment.
(Protocol design was changed so it no longer fit the description of this study.)
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mara Horwitz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177411
First received: September 12, 2005
Last updated: July 6, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoporosis
 Drug: Parathyroid Hormone-related Protein
 Phase 1

Study Type: Interventional
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)"

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The absence of any dose limiting toxicity criteria [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurement of vitamin D levels, markers of bone metabolism and fractional excretion of calcium measurements [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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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  Eligibility

Ages Eligible for Study:   24 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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. -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177411

Locations
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)
Investigators
Principal Investigator: Mara J. Horwitz, MD University of Pittsburgh
  More Information

Publications:

Responsible Party: Mara Horwitz, Associate Professor of Medicne, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177411     History of Changes
Other Study ID Numbers: IRB # 0507001, R01DK051081
Study First Received: September 12, 2005
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Endocrine System Diseases
MusculoSkeletal System Diseases
Hormone
Postmenopausal Women

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

ClinicalTrials.gov processed this record on June 18, 2013