One Week Comparison Study of PTH and PTHrP Infusions
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ClinicalTrials.gov Identifier: NCT01333267 |
Recruitment Status :
Withdrawn
First Posted : April 11, 2011
Last Update Posted : December 5, 2014
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Condition or disease | Intervention/treatment | Phase |
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Osteoporosis Hypercalcemia of Malignancy Hyperparathyroidism Bone Diseases, Endocrine | Drug: Parathyroid Hormone-related Protein (1-36) Drug: parathyroid hormone (1-34) Drug: PTH (1-34) and PTHrP (1-36) | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Official Title: | Comparison of Skeletal and Mineral Metabolism Responses in Healthy African-Americans and Caucasians Using a Continuous Seven-Day Parathyroid Hormone (PTH) or Parathyroid Hormone-related Protein (PTHrP) Infusion |
Study Start Date : | January 2015 |
Estimated Primary Completion Date : | July 2017 |
Estimated Study Completion Date : | July 2017 |

Arm | Intervention/treatment |
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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.
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Drug: Parathyroid Hormone-related Protein (1-36)
PTHrP (1-36) intravenously at 2 picomoles (pmols)/kg/hr for one week; doses will be increased by 2 picomoles (pmols)/kg/hr in subsequent subjects.
Other Names:
Drug: PTH (1-34) and PTHrP (1-36) 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.
Other Names:
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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.
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Drug: parathyroid hormone (1-34)
PTH (1-34) intravenously at 2 picomoles (pmols)/kg/hr for one week; doses will be increased by 2 picomoles (pmols)/kg/hr in subsequent subjects.
Other Names:
Drug: PTH (1-34) and PTHrP (1-36) 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.
Other Names:
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- Safety: The absence of any dose limiting toxicity (DLT) criteria consisting of one major criteria or two minor criteria. [ Time Frame: one week ]
- 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 ]

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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 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01333267
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Mara J. Horwitz, MD | University of Pittsburgh |
Responsible Party: | Mara Horwitz, Associate Professor, University of Pittsburgh School of Medicine, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT01333267 |
Other Study ID Numbers: |
PRO10060214 |
First Posted: | April 11, 2011 Key Record Dates |
Last Update Posted: | December 5, 2014 |
Last Verified: | December 2014 |
Endocrine System Diseases MusculoSkeletal System Disease Hormones Postmenopausal Women |
Bone metabolism Physiologic Properties African-Americans |
Osteoporosis Bone Diseases Bone Diseases, Endocrine Hypercalcemia Hyperparathyroidism Endocrine System Diseases Bone Diseases, Metabolic Musculoskeletal Diseases Metabolic Diseases Parathyroid Diseases |
Calcium Metabolism Disorders Water-Electrolyte Imbalance Hormones Testosterone Congeners Parathyroid Hormone Parathyroid Hormone-Related Protein Anabolic Agents Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Calcium-Regulating Hormones and Agents |