One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Endocrine |
| Therapuetic Areas: | Endocrinology, Rheumatology |
| Healthy: | No |
| Age Range: | 24 - 35 |
| Updated: | 4/21/2016 |
| Start Date: | January 2008 |
| End Date: | December 2009 |
Determining the Maximal Safe Dose of a Continuous Infusion of Parathyroid Hormone-related Protein(1-36): Effects on Bone Formation
This is a dose escalation study to determine the maximum tolerable dose of Parathyroid
Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators
plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and
progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy
(HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally,
the investigators will assess the direct influence of PTHrp on markers of bone turnover, and
plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.
Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators
plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and
progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy
(HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally,
the investigators will assess the direct influence of PTHrp on markers of bone turnover, and
plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.
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.
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 the
University of Pittsburgh Medical Center (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
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