The Bone-parathyroid Crosstalk in Primary Hyperparathyroidism
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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];
Disqualifiers
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
Trial 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 \[Bilezikian et al. 2014, Marcocci et al. 2015\].
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biomarker assays
Diagnostic testCirculating bone biomarkers assays
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: HPT patients1 intervention
Trial outcomes
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
Time frame
42 monthsSecondary outcomes
1
Effects of bone derived molecules on the biochemical phenotypes and parathyroid tumor cells function in HPT patients
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.
Time frame
42 monthsSponsors and contacts
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Source ClinicalTrials.gov
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