Clinical trial · Interventional
One Week Comparison Study of PTH and PTHrP Infusions
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Diseases, Endocrine | — | UNRESOLVED | — |
| Hypercalcemia of Malignancy | — | UNRESOLVED | — |
| Hyperparathyroidism | — | UNRESOLVED | — |
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| parathyroid hormone (1-34) | Drug | — | UNRESOLVED |
| Parathyroid Hormone-related Protein (1-36) | Drug | — | UNRESOLVED |
| PTH (1-34) and PTHrP (1-36) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PTHrP group
- description
- 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.
- interventionNames
- Drug: Parathyroid Hormone-related Protein (1-36)
- Drug: PTH (1-34) and PTHrP (1-36)
- type
- EXPERIMENTAL
- label
- PTH dosing group
- description
- 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.
- interventionNames
- Drug: parathyroid hormone (1-34)
- Drug: PTH (1-34) and PTHrP (1-36)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 24 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (52)
- BACKGROUNDDean T, Vilardaga JP, Potts JT Jr, Gardella TJ. Altered selectivity of parathyroid hormone (PTH) and PTH-related protein (PTHrP) for distinct conformations of the PTH/PTHrP receptor. Mol Endocrinol. 2008 Jan;22(1):156-66. doi: 10.1210/me.2007-0274. Epub 2007 Sep 13. PMID 17872377
- BACKGROUNDHorwitz MJ, Tedesco MB, Sereika SM, Syed MA, Garcia-Ocana A, Bisello A, Hollis BW, Rosen CJ, Wysolmerski JJ, Dann P, Gundberg C, Stewart AF. Continuous PTH and PTHrP infusion causes suppression of bone formation and discordant effects on 1,25(OH)2 vitamin D. J Bone Miner Res. 2005 Oct;20(10):1792-803. doi: 10.1359/JBMR.050602. Epub 2005 Jun 6. PMID 16160737
- BACKGROUNDHorwitz MJ, Tedesco MB, Sereika SM, Hollis BW, Garcia-Ocana A, Stewart AF. Direct comparison of sustained infusion of human parathyroid hormone-related protein-(1-36) [hPTHrP-(1-36)] versus hPTH-(1-34) on serum calcium, plasma 1,25-dihydroxyvitamin D concentrations, and fractional calcium excretion in healthy human volunteers. J Clin Endocrinol Metab. 2003 Apr;88(4):1603-9. doi: 10.1210/jc.2002-020773. PMID 12679445
- BACKGROUNDNelson DA, Jacobsen G, Barondess DA, Parfitt AM. Ethnic differences in regional bone density, hip axis length, and lifestyle variables among healthy black and white men. J Bone Miner Res. 1995 May;10(5):782-7. doi: 10.1002/jbmr.5650100515. PMID 7639113
- BACKGROUNDGeorge A, Tracy JK, Meyer WA, Flores RH, Wilson PD, Hochberg MC. Racial differences in bone mineral density in older men. J Bone Miner Res. 2003 Dec;18(12):2238-44. doi: 10.1359/jbmr.2003.18.12.2238. PMID 14672360
- BACKGROUNDKalkwarf HJ, Zemel BS, Gilsanz V, Lappe JM, Horlick M, Oberfield S, Mahboubi S, Fan B, Frederick MM, Winer K, Shepherd JA. The bone mineral density in childhood study: bone mineral content and density according to age, sex, and race. J Clin Endocrinol Metab. 2007 Jun;92(6):2087-99. doi: 10.1210/jc.2006-2553. Epub 2007 Feb 20.