Clinical trial · Observational
The Bone-parathyroid Crosstalk in Primary Hyperparathyroidism
Interactions Between Bone and Parathyroid Tumors in Patiens With Primary Hyperparathyroidism (The PARABONE Study)
NCT05556499CI-TRIAL-00061159PARABONEunknownClinicalTrials.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)
The PARABONE study aims to investigate the interaction between bone and parathyroid glands in patients with primary hyperparathyroidism (HPT). The study consists of a clinical part aimed at evaluating a series of circulating molecules of bone derivation (osteocalcin, molecules of the WNT pathway, RANKL, osteoprotegerin, Scelrostin, FGF23) in patients with HPT. In particular, the study has as its primary objective to identify the correlation between circulating levels of PTH and levels of GlaOC and GluOC in patients with HPT.
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 |
|---|---|---|---|
| Hyperparathyroidism, Primary | — | UNRESOLVED | — |
| Osteoporosis | — | UNRESOLVED | — |
| Parathyroid Neoplasms | Parathyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker assays | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HPT patients
- description
- Patients with primary hyperparathyroidism at diagnosis (HPT) treated with parathyroidectomy (HPT-PTX)
- interventionNames
- Diagnostic Test: Biomarker assays
Primary outcomes (1)
- measure
- Correlation between circulating GlaOC and PTH levels in HPT patients
- timeFrame
- 42 months
- description
- The study aims to investigate the effect of the circulating carboxylated osteocalcin isoform (GlaOC) on the biochemical phenotype in patients with HPT
Secondary outcomes (1)
- measure
- Effects of bone derived molecules on the biochemical phenotypes and parathyroid tumor cells function in HPT patients
- timeFrame
- 42 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion criteria for the HPT patient group: * diagnosis of primary hyperparathyroidism according to the most recent guidelines \[Marcocci et al. 2015\]; * adult patients (age ≥ 18 years); * signature of the informed consent. Inclusion criteria for the HPT-PTX patient group: * diagnosis of primary hyperparathyroidism with indication of surgical removal of the parathyroid tumor according to the most recent guidelines \[Marcocci et al. 2015\]; * adult patients (age ≥18 years); * signature of the informed consent. Exclusion Criteria: * Criteria for exclusion from the study are: * age \<18 years * diagnosis of hyperparathyroidism secondary to chronic renal failure or to vitamin D or calcium deficiency; * pregnancy or breastfeeding (self-declaration) * lack of informed consent
References
Publications (7)
- RESULTGianotti L, Piovesan A, Croce CG, Pellegrino M, Baffoni C, Cesario F, Visconti G, Borretta G, Tassone F. Interplay between serum osteocalcin and insulin sensitivity in primary hyperparathyroidism. Calcif Tissue Int. 2011 Mar;88(3):231-7. doi: 10.1007/s00223-010-9453-1. Epub 2011 Jan 5. PMID 21207016
- RESULTMarcocci C, Brandi ML, Scillitani A, Corbetta S, Faggiano A, Gianotti L, Migliaccio S, Minisola S. Italian Society of Endocrinology Consensus Statement: definition, evaluation and management of patients with mild primary hyperparathyroidism. J Endocrinol Invest. 2015 May;38(5):577-93. doi: 10.1007/s40618-015-0261-3. Epub 2015 Mar 28. No abstract available. PMID 25820553
- RESULTMaser RE, Lenhard MJ, Pohlig RT, Balagopal PB, Abdel-Misih R. Effect of parathyroidectomy on osteopontin and undercarboxylated osteocalcin in patients with primary hyperparathyroidism. Endocr Res. 2018 Feb;43(1):21-28. doi: 10.1080/07435800.2017.1369432. Epub 2017 Sep 22. PMID 28937873
- RESULTMendonca ML, Batista SL, Nogueira-Barbosa MH, Salmon CE, Paula FJ. Primary Hyperparathyroidism: The Influence of Bone Marrow Adipose Tissue on Bone Loss and of Osteocalcin on Insulin Resistance. Clinics (Sao Paulo). 2016 Aug;71(8):464-9. doi: 10.6061/clinics/2016(08)09. PMID 27626477
- RESULTThier M, Daudi S, Bergenfelz A, Almquist M. Predictors of multiglandular disease in primary hyperparathyroidism. Langenbecks Arch Surg. 2018 Feb;403(1):103-109. doi: 10.1007/s00423-017-1647-9. Epub 2018 Jan 2. PMID 29294178
- RESULTParveen B, Parveen A, Vohora D. Biomarkers of Osteoporosis: An Update. Endocr Metab Immune Disord Drug Targets. 2019;19(7):895-912. doi: 10.2174/1871530319666190204165207. PMID 30727928
- RESULTBilezikian JP, Brandi ML, Eastell R, Silverberg SJ, Udelsman R, Marcocci C, Potts JT Jr. Guidelines for the management of asymptomatic primary hyperparathyroidism: summary statement from the Fourth International Workshop. J Clin Endocrinol Metab. 2014 Oct;99(10):3561-9. doi: 10.1210/jc.2014-1413. Epub 2014 Aug 27.