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Trial · Interventional

WithdrawnPhase 1Registry data

One Week Comparison Study of PTH and PTHrP Infusions

NCTNCT01333267 (opens ClinicalTrials.gov in a new tab)Other idPRO10060214
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 1
Enrollment
0 participants (actual)
Sponsor
University of Pittsburgh · Other
Design
Not randomized · Single masking
Countries
1 country

United States

Start
Jan 2015
Primary completion
Jul 2017 (estimated)
Completion
Jul 2017 (estimated)
First posted
11 Apr 2011 (estimated)
Last update posted
5 Dec 2014 (estimated)
Conditions
Osteoporosis · Hypercalcemia of Malignancy · Hyperparathyroidism · Bone Diseases, Endocrine

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 1

    One Week Comparison Study of PTH and PTHrP Infusions

    NCT01333267

    Jan 2015 to est. Jul 2017

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, or Parathyroid Hormone, PTH, that can be given safely over one week in healthy African-American volunteers. The investigators plan to infuse low doses of intravenous PTHrP or PTH 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 and PTH on vitamin D metabolism, markers of bone turnover, and fractional excretion of calcium. These results will be compared to previous studies of Caucasian volunteers.

Interventions

  • Parathyroid Hormone-related Protein (1-36)Drug
  • parathyroid hormone (1-34)Drug
  • PTH (1-34) and PTHrP (1-36)Drug

Arms2

  • Experimental

    PTHrP group

    Subjects receive PTHrP(1-36) starting with doses of 2 picomoles (pmols)/kg/hr for one week. Subsequent dosing groups are determined by the response to PTHrP doses.

  • Experimental

    PTH dosing group

    Subjects receive PTH(1-34) starting with doses of 2 picomoles (pmols)/kg/hr for one week. Subsequent dosing groups are determined by the response to PTH doses.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · one week

Secondary outcomes(1)

  1. Blood collections analyzed for measurements of PTH(1-34), PTH(1-84), 25-OH vitamin D, 1,25(OH)2 vitamin D, markers of bone metabolism, and fractional excretion of calcium measurements.

    Time frame · one week

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2001

12 results

Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.

Neer et al. 2001The New England journal of medicinecited by 3,051

PMID 11346808DOI 10.1056/nejm200105103441904PUB-11346808

Rights unknown12 results
Source linkSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 24 Years up to 35 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy African-American subjects of both sexes between the ages of 24-35 years, who are able to spend one week on the Clinical \& Translational Research Center (CTRC) at the University of Pittsburgh Medical Center (UPMC) Montefiore. Exclusion Criteria: * Subjects with cardiac, vascular, renal (serum creatinine \> 1.5), pulmonary, endocrine, musculoskeletal, hepatic, hematologic, malignant, or rheumatologic disease will be excluded. * Those found to have vitamin D deficiency, defined as a 25-OH vitamin D level \< 10 ng/mL will also be excluded. * Additionally, those with BMI \> 30, anemia (hematocrit \< 36% in women, \<40% in men), significant alcohol use, illicit drug use, hypertension (BP\>160/90), or baseline hypotension (systolic blood pressure \< 90mmHg) will be excluded. * Those taking chronic medications (except oral contraceptive pills (OCP's) or stable doses of thyroid replacement) or those who have received an investigational drug in the past 90 days will also be excluded. * Prior participants in PTH or PTHrP studies will not be eligible to participate. * Additionally pregnant women and lactating women will be excluded; all women will have a urine pregnancy test performed immediately before starting the study.

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