- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05556499
The Bone-parathyroid Crosstalk in Primary Hyperparathyroidism (PARABONE)
Interactions Between Bone and Parathyroid Tumors in Patiens With Primary Hyperparathyroidism (The PARABONE Study)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sabrina Corbetta, PhD, MD
- Phone Number: +39 02 83506781
- Email: sabrina.corbetta@unimi.it
Study Locations
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Milan, Italy, 20157
- IRCCS Istituto Ortopedico Galeazzi
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Contact:
- Sabrina Corbetta, PhD, MD
- Email: sabrina.corbetta@unimi.it
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Contact:
- Sara Zacchetti
- Email: sara.zacchetti@grupposandonato.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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].
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HPT patients
Patients with primary hyperparathyroidism at diagnosis (HPT) treated with parathyroidectomy (HPT-PTX)
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Circulating bone biomarkers assays
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between circulating GlaOC and PTH levels in HPT patients
Time Frame: 42 months
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The study aims to investigate the effect of the circulating carboxylated osteocalcin isoform (GlaOC) on the biochemical phenotype in patients with HPT
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42 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of bone derived molecules on the biochemical phenotypes and parathyroid tumor cells function in HPT patients
Time Frame: 42 months
|
Correlation between the clinical and biochemical characteristics of HPT patients with circulating levels of the two isoforms of osteocalcin and other hormones produced by bone (molecules of the WNT pathway, RANKL, Osteoprotegerin, Sclerostin, FGF23, IL-17).
Analysis of the expression of circulating lncRNAs and microRNAs in patients with HPT in relation to the osteo-metabolic state.
Analysis of the expression pattern of genes involved in parathyroid tumorigenesis and in bone-parathyroid crosstalk, lncRNAs and microRNAs in parathyroid cancer cells in order to further define the heterogeneity of the adenoma histotype in relation to the osteo-metabolic state.Define the biological effect of the hormones released from bone on parathyroid cancer cells.
Define the biological effect and the interaction with the parathyroid function of the hormones released from bone in HEK293A models transfected with the CASR and / or transfected with the receptors of the molecules released by bone.
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42 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sabrina Corbetta, PhD, MD, IRCCS Istituto Ortopedico Galeazzi
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PARABONE (L4126)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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