Creation, Management and Analysis of a National Database of Patients Affected by Hypoparathyroidism or Pseudohypoparathyroidism

Status: Recruiting
Location: See all (41) locations...
Study Type: Observational
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. The study itself does not involve any medical intervention or drug administration. Pharmacological treatments for which data on response to therapy will be collected in the database, are those administered to patients for the control/treatment of hypoparathyroidism or pseudohypoparathyroidism, regardless of their inclusion in this observational study.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Cohort 1: chronic hypoparathyroidism (all etiological forms)

• Cohort 2: pseudohypoparathyroidism

Locations
Other Locations
Italy
SC Pediatria e Pronto Soccorso Pediatrico - AOU SS. Antonio e Biagio e C. Arrigo
NOT_YET_RECRUITING
Alessandria
U.O.C. Endocrinologia, Azienda Ospedaliero Universitaria Policlinico Consorziale, Università degli Studi di Bari Aldo Moro
NOT_YET_RECRUITING
Bari
Unità di Pediatria, IRCCS Azienda Ospedaliero-Universitaria di Bologna
NOT_YET_RECRUITING
Bologna
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
NOT_YET_RECRUITING
Bologna
Centro di Auxoendocrinologia e Genetica Medica della Clinica Pediatrica degli Spedali Civili di Brescia
NOT_YET_RECRUITING
Brescia
Endocrinologia e Diabetologia, Azienda Ospedaliero-Universitaria di Cagliari, Presidio Ospedaliero Policlinico di Monserrato
NOT_YET_RECRUITING
Cagliari
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
RECRUITING
Ferrara
Diabetologia e Endocrinologia, Auxoendocrinologia, Children's Hospital Meyer IRCCS
NOT_YET_RECRUITING
Firenze
SOD Malattie del Metabolismo Minerale ed Osseo, Azienda Ospedaliero-Universitaria Careggi
RECRUITING
Firenze
Ospedale Casa Sollievo della Sofferenza
NOT_YET_RECRUITING
Foggia
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
NOT_YET_RECRUITING
Genova
Clinica Endocrinologica, Dipartimento di Medicina Interna e Specialità Mediche (DiMI), IRCCS Ospedale Policlinico San Martino, Università di Genova
NOT_YET_RECRUITING
Genova
U.O.S.D. Centro Malattie Rare · Dipartimento di Pediatria IRCCS Ospedale Pediatrico Giannina Gaslini
NOT_YET_RECRUITING
Genova
Dipartimento di Patologia Umana dell'adulto e dell'età evolutiva Gaetano Barresi, Università degli Studi di Messina
NOT_YET_RECRUITING
Messina
UOC di Endocrinologia, AOU Policlinico G. Martino, Dipartimento di Patologia Umana DETEV, Università di Messina
NOT_YET_RECRUITING
Messina
Dipartimento di Malattie Endocrino-Metaboliche, IRCCS Istituto Auxologico Italiano
NOT_YET_RECRUITING
Milano
Endocrinologia Infantile, UOU di Pediatria, IRCCS Ospedale San Raffaele
NOT_YET_RECRUITING
Milano
IRCCS Ospedale San Raffaele
NOT_YET_RECRUITING
Milano
SC Endocrinologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milano
Dipartimento di Medicina Clinica e Chirurgia; Unità di Endocrinologia, Diabetologia e Andrologia; Università degli Studi di Napoli Federico II
NOT_YET_RECRUITING
Napoli
UOC di Endocrinologia e Malattie del Metabolismo, AOU Università degli Studi della Campania Luigi Vanvitelli
NOT_YET_RECRUITING
Napoli
UOS di Endocrinologia Pediatrica, Dipartimento Materno Infantile, AOU Federico II
NOT_YET_RECRUITING
Napoli
UOSD Malattie Neuro-Endocrine, Centro Obesità, Dipartimento di Neuroscienze e Riabilitazione, AORN Santobono-Pausilipon
NOT_YET_RECRUITING
Napoli
SCDU Endocrinologia Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
NOT_YET_RECRUITING
Novara
Endocrinologia, Clinica Polispecialistica San Carlo
NOT_YET_RECRUITING
Paderno Dugnano
Unità di Chirurgia Endocrina, Dipartimento di Chirurgia, Oncologia e Gastroenterologia, Università di Padova
NOT_YET_RECRUITING
Padova
UOC Endocrinologia, DIMED, Azienda Ospedaliero-Universitaria di Padova
NOT_YET_RECRUITING
Padova
Unità Operativa Endocrinologia 2, Azienda Ospedaliera Universitaria Pisana
NOT_YET_RECRUITING
Pisa
Dipartimento di Medicina Sperimentale, Sapienza Università di Roma, Roma - UOC Endocrinologia, Policlinico Umberto I di Roma
NOT_YET_RECRUITING
Roma
Unità di Endocrinologia e Andrologia, Dipartimento di Medicina Clinica e Molecolare, AOU Sant'Andrea, Centro di eccellenza ENETS, Università Sapienza di Roma
NOT_YET_RECRUITING
Roma
UOC di Endocrinologia e Diabetologia, UOS di Endocrinologia Pediatrica, IRCCS Ospedale Pediatrico Bambino Gesù
NOT_YET_RECRUITING
Roma
UOC Patologie osteo-metaboliche e della tiroide, Fondazione Policlinico universitario Campus Bio-Medico
NOT_YET_RECRUITING
Roma
UOC di Endocrinologia, Diabetologia e Andrologia Medica, IRCCS Humanitas Research Hospital
NOT_YET_RECRUITING
Rozzano
Donatello Bone Clinic, Casa di Cura Villa Donatello
RECRUITING
Sesto Fiorentino
Dipartimento di Scienze Mediche, Chirurgiche e Neuroscienze, Policlinico Santa Maria delle Scotte, Università di Siena
NOT_YET_RECRUITING
Siena
Endocrinologia Pediatrica Ospedale Infantile regina Margherita-Dipartimento di Scienze di Sanità Pubblica e Pediatriche, Università degli studi di Torino
NOT_YET_RECRUITING
Torino
SCDU Endocrinologia Diabetologia e Malattie del Metabolismo, AOU Città della Salute e della Scienza di Torino, Università di Torino
NOT_YET_RECRUITING
Torino
SCDU Endocrinologia Oncologica, AOU Città della Salute e della Scienza di Torino, Università di Torino
NOT_YET_RECRUITING
Torino
IRCCS Materno-Infantile Burlo Garofolo
RECRUITING
Trieste
SOC Endocrinologia, Azienda Sanitaria-Universitaria Friuli Centrale
NOT_YET_RECRUITING
Udine
UOS di Endocrinologia, Policlinico GB Rossi, Azienda Ospedaliera Universitaria Integrata di Verona
NOT_YET_RECRUITING
Verona
Contact Information
Primary
Maria Luisa Brandi, MD, PhD
marialuisa@marialuisabrandi.it
0039-055-2336663
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2034-11-04
Participants
Target number of participants: 600
Treatments
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.
Sponsors
Leads: F.I.R.M.O. - Fondazione Italiana Ricerca sulle Malattie dell'Osso - Ente del Terzo Settore

This content was sourced from clinicaltrials.gov

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