Clinical trial · Interventional
One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study
Determining the Maximal Safe Dose of a Continuous Infusion of Parathyroid Hormone-related Protein(1-36): Effects on Bone Formation
NCT00580788CI-TRIAL-00020874completedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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, 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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Humoral Hypercalcemia of Malignancy | — | UNRESOLVED | — |
| Hyperparathyroidism | — | UNRESOLVED | — |
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTHrP (1-36) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- PTHrP(1-36) 2 pmol/kg/hr
- description
- PTHrP(1-36) at 2 picomoles/kg/hr for one week.
- interventionNames
- Drug: PTHrP (1-36)
- type
- EXPERIMENTAL
- label
- PTHrP (1-36) 4 pmol/kg/hr
- description
- PTHrP(1-36) at 4 picomoles/kg/hr for one week.
- interventionNames
- Drug: PTHrP (1-36)
- type
- EXPERIMENTAL
- label
- PTHrP(1-36) 5 pmol/kg/hr
- description
- PTHrP(1-36) at 5 picomoles/kg/hr for one week.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 24 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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
References
Publications (27)
- BACKGROUNDJuppner H, Abou-Samra AB, Freeman M, Kong XF, Schipani E, Richards J, Kolakowski LF Jr, Hock J, Potts JT Jr, Kronenberg HM, et al. A G protein-linked receptor for parathyroid hormone and parathyroid hormone-related peptide. Science. 1991 Nov 15;254(5034):1024-6. doi: 10.1126/science.1658941. PMID 1658941
- BACKGROUNDOrloff JJ, Wu TL, Heath HW, Brady TG, Brines ML, Stewart AF. Characterization of canine renal receptors for the parathyroid hormone-like protein associated with humoral hypercalcemia of malignancy. J Biol Chem. 1989 Apr 15;264(11):6097-103. PMID 2539369
- BACKGROUNDOrloff JJ, Ribaudo AE, McKee RL, Rosenblatt M, Stewart AF. A pharmacological comparison of parathyroid hormone receptors in human bone and kidney. Endocrinology. 1992 Oct;131(4):1603-11. doi: 10.1210/endo.131.4.1327716. PMID 1327716
- BACKGROUNDOrloff JJ, Reddy D, de Papp AE, Yang KH, Soifer NE, Stewart AF. Parathyroid hormone-related protein as a prohormone: posttranslational processing and receptor interactions. Endocr Rev. 1994 Feb;15(1):40-60. doi: 10.1210/edrv-15-1-40. PMID 8156938
- BACKGROUNDSamuels MH, Veldhuis J, Cawley C, Urban RJ, Luther M, Bauer R, Mundy G. Pulsatile secretion of parathyroid hormone in normal young subjects: assessment by deconvolution analysis. J Clin Endocrinol Metab. 1993 Aug;77(2):399-403. doi: 10.1210/jcem.77.2.8345044. PMID 8345044
- BACKGROUNDPrank K, Nowlan SJ, Harms HM, Kloppstech M, Brabant G, Hesch RD, Sejnowski TJ. Time series prediction of plasma hormone concentration. Evidence for differences in predictability of parathyroid hormone secretion between osteoporotic patients and normal controls. J Clin Invest. 1995 Jun;95(6):2910-9. doi: 10.1172/JCI117998. PMID 7769133
- BACKGROUNDSchmitt CP, Obry J, Feneberg R, Veldhuis JD, Mehls O, Ritz E, Schaefer F. Beta1-adrenergic blockade augments pulsatile PTH secretion in humans. J Am Soc Nephrol. 2003 Dec;14(12):3245-50. doi: 10.1097/01.asn.0000101240.47747.7f.