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Determining the Maximal Safe Dose of a Continuous Infusion of Parathyroid Hormone-related Protein(1-36): Effects on Bone Formation


Phase 1
24 Years
35 Years
Not Enrolling
Both
Osteoporosis, Humoral Hypercalcemia of Malignancy, Hyperparathyroidism

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Trial Information

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.


Inclusion Criteria:



- Healthy caucasian subjects of both sexes between the ages of 24-35 years, who are
able to spend one week on the Clinical & Translational Research Center at UPMC
Montefiore

Exclusion Criteria:

- Pregnancy

- Any cardiac, renal, pulmonary, endocrine, musculoskeletal, hepatic, hematological,
malignant or rheumatologic diseases

- Body mass index great than 30

- Anemia

- Significant alcohol or drug abuse

- Baseline hypotension or hypertension

- Abnormal screening labs

- Use of certain chronic medications excluding oral contraceptives

- Receiving an investigational drug in the last 90 days

- Previously receiving PTH or PTHrP

- African-American race

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Outcome Measure:

The absence of any dose limiting toxicity (DLT) criteria consisting of one major criteria or two minor criteria.

Outcome Time Frame:

one week

Safety Issue:

Yes

Principal Investigator

Mara J Horwitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

PRO07040081

NCT ID:

NCT00580788

Start Date:

January 2008

Completion Date:

December 2009

Related Keywords:

  • Osteoporosis
  • Humoral Hypercalcemia of Malignancy
  • Hyperparathyroidism
  • Endocrine System Diseases
  • MusculoSkeletal System Diseases
  • Hormones
  • Malignancy
  • Postmenopausal Women
  • Bone metabolism
  • Neoplasms
  • Hypercalcemia
  • Hyperparathyroidism
  • Osteoporosis

Name

Location
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213