The Bone-parathyroid Crosstalk in Primary Hyperparathyroidism

NCT05556499 | Not Yet Recruiting

• 1 other identifier: PARABONE (L4126)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hyperparathyroidism, Primary; Osteoporosis; Parathyroid Neoplasms

Outcome Measures

Primary Outcomes (1)

• Correlation between circulating GlaOC and PTH levels in HPT patients

  The study aims to investigate the effect of the circulating carboxylated osteocalcin isoform (GlaOC) on the biochemical phenotype in patients with HPT

  42 months

Secondary Outcomes (1)

• Effects of bone derived molecules on the biochemical phenotypes and parathyroid tumor cells function in HPT patients

  42 months

Study Arms (1)

HPT patients

Patients with primary hyperparathyroidism at diagnosis (HPT) treated with parathyroidectomy (HPT-PTX)

Diagnostic Test: Biomarker assays

Interventions

Biomarker assays DIAGNOSTIC_TEST

Circulating bone biomarkers assays

HPT patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients aged ≥ 18 years with a diagnosis of HPT according to the most recent guidelines will be enrolled in the study \[Marcocci et al. 2015\] with and without indication for surgical treatment. Serum and plasma samples will be collected from all patients with HPT and parathyroid tumor samples from patients diagnosed with HPT with indication for surgical treatment according to the guidelines \[Bilezikian et al. 2014, Marcocci et al. 2015\].

You may qualify if:

• diagnosis of primary hyperparathyroidism according to the most recent guidelines \[Marcocci et al. 2015\];
• adult patients (age ≥ 18 years);
• signature of the informed consent.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20157, Italy

Location

Related Publications (7)

• Gianotti 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 RESULT

• Marcocci 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 RESULT

• Maser 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 RESULT

• Mendonca 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 RESULT

• Thier 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 RESULT

• Parveen 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 RESULT

• Bilezikian 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.

  PMID: 25162665 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Parathyroid tumor samples derived from patients undergoing excisional surgery and peripheral blood samples at diagnosis will be collected

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Osteoporosis; Parathyroid Neoplasms

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Sabrina Corbetta, PhD, MD

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Corbetta, PhD, MD

CONTACT

+39 02 83506781; sabrina.corbetta@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 27, 2022
• Study Start: October 1, 2022
• Primary Completion: May 24, 2026
• Study Completion (Estimated): June 24, 2026
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)