Institution of an Italian Multicenter Database of Patients Affected by Hypoparathyroidism or Pseudohypoparathyroidism
Creation, Management and Analysis of a National Database of Patients Affected by Hypoparathyroidism or Pseudohypoparathyroidism
1 other identifier
observational
600
1 country
41
Brief Summary
The goal of this observational study is to create, manage and analyze a multicenter national database of patients affected by hypoparathyroidism or pseudohypoparathyroidism, aimed at collecting and studying anamnestic, diagnostic, genetic, clinical, and therapeutic data in a relatively wide number of patients with these two rare pathologies, in Italy. The study will include 41 specialist clinical centers of endocrinology, pediatric endocrinology, pediatrics, and endocrine surgery, located throughout the Italian territory, and to which patients refer from all the 20 regions of Italy. Data will be collected over time, both in retrospective and prospective manners, during the 10-year duration of the study, starting from the recruiting visit (basal visit) and then during each follow-up visits patients will undergo for the control of disease at the recruiting clinical centers. Collected data will include both the most classic traits of the pathology and the less common ones, with the final goal of refining and deepening medical knowledge in the field of these two clinical conditions affecting parathyroid function and calcium homeostasis, and, thus, to be able to define optimal clinical and therapeutic management of patients, improving their quality of life. The main aspects this observational study aims to assess and clarify are:
- 1.Evaluation of prevalence and incidence of hypoparathyroidism, globally and in its different etiological forms, and of pseudohypoparathyroidism in Italy.
- 2.Clinical characterization of different etiological forms of hypoparathyroidism, through both cross-sectional and longitudinal analyses of collected data.
- 3.Clinical characterization of pseudohypoparathyroidism, through both cross-sectional and longitudinal analyses of collected data.
- 4.Over time collection of data on bone status and bone fragility in patients with hypoparathyroidism and pseudohypoparathyroidism, to evaluate the prevalence and incidence of fragility fractures in these patients, globally and also based on gender, age, and disease etiology.
- 5.Over time evaluation of response to pharmacological therapies in patients with hypoparathyroidism and pseudohypoparathyroidism The study will include two independent cohorts of female and male patients of any age, one including patients with chronic hypoparathyroidism of each etiological forms (cohort 1), and one including patients with pseudohypoparathyroidism (cohort 2). The study does not include either any control group/comparison group or healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2024
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedStudy Start
First participant enrolled
November 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 4, 2034
January 23, 2025
October 1, 2024
10 years
October 7, 2024
January 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Prevalence and incidence evaluation
Evaluation of prevalence and incidence of hypoparathyroidism globally and in its different etiological forms, and of pseudohypoparathyroidism in Italy
Through study completion, an average of 10 years
Clinical characterization of hypoparathyroidism
Clinical characterization of different etiological forms of hypoparathyroidism, through both cross-sectional and longitudinal analyses of collected data
Through study completion, an average of 10 years
Clinical characterization of pseudohypoparathyroidism
Clinical characterization of pseudohypoparathyroidism, through both cross-sectional and longitudinal analyses of collected data
Through study completion, an average of 10 years
Bone fragility in patients with hypoparathyroidism and pseudohypoparathyroidism
Evaluation of over time prevalence and incidence of fragility fractures in patients with hypoparathyroidism and pseudohypoparathyroidism, globally and also based on gender, age, and disease etiology
Through study completion, an average of 10 years
Therapy response in patients with hypoparathyroidism and pseudohypoparathyroidism
Over time analysis of responses to pharmacological therapies in in patients with hypoparathyroidism and pseudohypoparathyroidism
Through study completion, an average of 10 years
Study Arms (2)
Patients with hypoparathyroidism
Male and female patients of any age who are affected by chronic hypoparathyroidism. The observation study does not include any type of intervention.
Patients with pseudohypoparathyroidism
Male and female patients of any age who are affected by pseudohypoparathyroidism. The observation study does not include any type of intervention.
Eligibility Criteria
Two independent cohorts of female and male patients of any age, one including patients with chronic hypoparathyroidism (cohort 1), and one including patients with pseudohypoparathyroidism (cohort 2).
You may qualify if:
- Cohort 1: chronic hypoparathyroidism (all etiological forms)
- Cohort 2: pseudohypoparathyroidism
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
SC Pediatria e Pronto Soccorso Pediatrico - AOU SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy
U.O.C. Endocrinologia, Azienda Ospedaliero Universitaria Policlinico Consorziale, Università degli Studi di Bari "Aldo Moro"
Bari, Italy
Unità di Pediatria, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
UOC Endocrinologia e Prevenzione e Cura del Diabete, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Alma Mater Studiorum Università di Bologna
Bologna, Italy
Centro di Auxoendocrinologia e Genetica Medica della Clinica Pediatrica degli Spedali Civili di Brescia
Brescia, Italy
Endocrinologia e Diabetologia, Azienda Ospedaliero-Universitaria di Cagliari, Presidio Ospedaliero Policlinico di Monserrato
Cagliari, Italy
UO Endocrinologia e Malattie del Ricambio, Azienda Ospedaliero Universitaria di Ferrara, Sezione di Endocrinologia, Geriatria e Medicina Interna, Dipartimento di Scienze Mediche, Università degli Studi di Ferrara
Ferrara, Italy
Diabetologia e Endocrinologia, Auxoendocrinologia, Children's Hospital Meyer IRCCS
Florence, Italy
SOD Malattie del Metabolismo Minerale ed Osseo, Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Ospedale Casa Sollievo della Sofferenza
Foggia, Italy
Centro di Alta Specialità in Osteoporosi Pediatrica e Malattie del Metabolismo Calcio-Fosforo, U.O.C. Clinica Pediatrica, Dipartimento di Scienze Pediatriche Generali e Specialistiche IRCCS Istituto Giannina Gaslini
Genova, Italy
Clinica Endocrinologica, Dipartimento di Medicina Interna e Specialità Mediche (DiMI), IRCCS Ospedale Policlinico San Martino, Università di Genova
Genova, Italy
U.O.S.D. Centro Malattie Rare · Dipartimento di Pediatria IRCCS Ospedale Pediatrico Giannina Gaslini
Genova, Italy
Dipartimento di Patologia Umana dell'adulto e dell'età evolutiva "Gaetano Barresi", Università degli Studi di Messina
Messina, Italy
UOC di Endocrinologia, AOU Policlinico G. Martino, Dipartimento di Patologia Umana DETEV, Università di Messina
Messina, Italy
Dipartimento di Malattie Endocrino-Metaboliche, IRCCS Istituto Auxologico Italiano
Milan, Italy
Endocrinologia Infantile, UOU di Pediatria, IRCCS Ospedale San Raffaele
Milan, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
SC Endocrinologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Dipartimento di Medicina Clinica e Chirurgia; Unità di Endocrinologia, Diabetologia e Andrologia; Università degli Studi di Napoli Federico II
Napoli, Italy
UOC di Endocrinologia e Malattie del Metabolismo, AOU Università degli Studi della Campania Luigi Vanvitelli
Napoli, Italy
UOS di Endocrinologia Pediatrica, Dipartimento Materno Infantile, AOU Federico II
Napoli, Italy
UOSD Malattie Neuro-Endocrine, Centro Obesità, Dipartimento di Neuroscienze e Riabilitazione, AORN Santobono-Pausilipon
Napoli, Italy
SCDU Endocrinologia Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy
Endocrinologia, Clinica Polispecialistica San Carlo
Paderno Dugnano, Italy
Unità di Chirurgia Endocrina, Dipartimento di Chirurgia, Oncologia e Gastroenterologia, Università di Padova
Padua, Italy
UOC Endocrinologia, DIMED, Azienda Ospedaliero-Universitaria di Padova
Padua, Italy
Unità Operativa Endocrinologia 2, Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Dipartimento di Medicina Sperimentale, "Sapienza" Università di Roma, Roma - UOC Endocrinologia, Policlinico Umberto I di Roma
Roma, Italy
Unità di Endocrinologia e Andrologia, Dipartimento di Medicina Clinica e Molecolare, AOU Sant'Andrea, Centro di eccellenza ENETS, Università Sapienza di Roma
Roma, Italy
UOC di Endocrinologia e Diabetologia, UOS di Endocrinologia Pediatrica, IRCCS Ospedale Pediatrico Bambino Gesù
Roma, Italy
UOC Patologie osteo-metaboliche e della tiroide, Fondazione Policlinico universitario Campus Bio-Medico
Roma, Italy
UOC di Endocrinologia, Diabetologia e Andrologia Medica, IRCCS Humanitas Research Hospital
Rozzano, Italy
Donatello Bone Clinic, Casa di Cura Villa Donatello
Sesto Fiorentino, Italy
Dipartimento di Scienze Mediche, Chirurgiche e Neuroscienze, Policlinico Santa Maria delle Scotte, Università di Siena
Siena, Italy
Endocrinologia Pediatrica Ospedale Infantile regina Margherita-Dipartimento di Scienze di Sanità Pubblica e Pediatriche, Università degli studi di Torino
Torino, Italy
SCDU Endocrinologia Diabetologia e Malattie del Metabolismo, AOU Città della Salute e della Scienza di Torino, Università di Torino
Torino, Italy
SCDU Endocrinologia Oncologica, AOU Città della Salute e della Scienza di Torino, Università di Torino
Torino, Italy
IRCCS Materno-Infantile Burlo Garofolo
Trieste, Italy
SOC Endocrinologia, Azienda Sanitaria-Universitaria Friuli Centrale
Udine, Italy
UOS di Endocrinologia, Policlinico GB Rossi, Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2024
First Posted
October 17, 2024
Study Start
November 4, 2024
Primary Completion (Estimated)
November 4, 2034
Study Completion (Estimated)
November 4, 2034
Last Updated
January 23, 2025
Record last verified: 2024-10