Actively Recruiting
Institution of an Italian Multicenter Database of Patients Affected by Hypoparathyroidism or Pseudohypoparathyroidism
Led by F.I.R.M.O. - Fondazione Italiana Ricerca sulle Malattie dell'Osso - Ente del Terzo Settore · Updated on 2025-01-23
600
Participants Needed
41
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Institution of an Italian Multicenter Database of Patients Affected by Hypoparathyroidism or Pseudohypoparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic hypoparathyroidism of any cause
- Diagnosed with pseudohypoparathyroidism
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 41 locations
1
SC Pediatria e Pronto Soccorso Pediatrico - AOU SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy
Not Yet Recruiting
2
U.O.C. Endocrinologia, Azienda Ospedaliero Universitaria Policlinico Consorziale, Università degli Studi di Bari "Aldo Moro"
Bari, Italy
Not Yet Recruiting
3
Unità di Pediatria, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
Not Yet Recruiting
4
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
Not Yet Recruiting
5
Centro di Auxoendocrinologia e Genetica Medica della Clinica Pediatrica degli Spedali Civili di Brescia
Brescia, Italy
Not Yet Recruiting
6
Endocrinologia e Diabetologia, Azienda Ospedaliero-Universitaria di Cagliari, Presidio Ospedaliero Policlinico di Monserrato
Cagliari, Italy
Not Yet Recruiting
7
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
Actively Recruiting
8
Diabetologia e Endocrinologia, Auxoendocrinologia, Children's Hospital Meyer IRCCS
Florence, Italy
Not Yet Recruiting
9
SOD Malattie del Metabolismo Minerale ed Osseo, Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Actively Recruiting
10
Ospedale Casa Sollievo della Sofferenza
Foggia, Italy
Not Yet Recruiting
11
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
Not Yet Recruiting
12
Clinica Endocrinologica, Dipartimento di Medicina Interna e Specialità Mediche (DiMI), IRCCS Ospedale Policlinico San Martino, Università di Genova
Genova, Italy
Not Yet Recruiting
13
U.O.S.D. Centro Malattie Rare · Dipartimento di Pediatria IRCCS Ospedale Pediatrico Giannina Gaslini
Genova, Italy
Not Yet Recruiting
14
Dipartimento di Patologia Umana dell'adulto e dell'età evolutiva "Gaetano Barresi", Università degli Studi di Messina
Messina, Italy
Not Yet Recruiting
15
UOC di Endocrinologia, AOU Policlinico G. Martino, Dipartimento di Patologia Umana DETEV, Università di Messina
Messina, Italy
Not Yet Recruiting
16
Dipartimento di Malattie Endocrino-Metaboliche, IRCCS Istituto Auxologico Italiano
Milan, Italy
Not Yet Recruiting
17
Endocrinologia Infantile, UOU di Pediatria, IRCCS Ospedale San Raffaele
Milan, Italy
Not Yet Recruiting
18
IRCCS Ospedale San Raffaele
Milan, Italy
Not Yet Recruiting
19
SC Endocrinologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Not Yet Recruiting
20
Dipartimento di Medicina Clinica e Chirurgia; Unità di Endocrinologia, Diabetologia e Andrologia; Università degli Studi di Napoli Federico II
Naples, Italy
Not Yet Recruiting
21
UOC di Endocrinologia e Malattie del Metabolismo, AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, Italy
Not Yet Recruiting
22
UOS di Endocrinologia Pediatrica, Dipartimento Materno Infantile, AOU Federico II
Naples, Italy
Not Yet Recruiting
23
UOSD Malattie Neuro-Endocrine, Centro Obesità, Dipartimento di Neuroscienze e Riabilitazione, AORN Santobono-Pausilipon
Naples, Italy
Not Yet Recruiting
24
SCDU Endocrinologia Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy
Not Yet Recruiting
25
Endocrinologia, Clinica Polispecialistica San Carlo
Paderno Dugnano, Italy
Not Yet Recruiting
26
Unità di Chirurgia Endocrina, Dipartimento di Chirurgia, Oncologia e Gastroenterologia, Università di Padova
Padova, Italy
Not Yet Recruiting
27
UOC Endocrinologia, DIMED, Azienda Ospedaliero-Universitaria di Padova
Padova, Italy
Not Yet Recruiting
28
Unità Operativa Endocrinologia 2, Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Not Yet Recruiting
29
Dipartimento di Medicina Sperimentale, "Sapienza" Università di Roma, Roma - UOC Endocrinologia, Policlinico Umberto I di Roma
Roma, Italy
Not Yet Recruiting
30
Unità di Endocrinologia e Andrologia, Dipartimento di Medicina Clinica e Molecolare, AOU Sant'Andrea, Centro di eccellenza ENETS, Università Sapienza di Roma
Roma, Italy
Not Yet Recruiting
31
UOC di Endocrinologia e Diabetologia, UOS di Endocrinologia Pediatrica, IRCCS Ospedale Pediatrico Bambino Gesù
Roma, Italy
Not Yet Recruiting
32
UOC Patologie osteo-metaboliche e della tiroide, Fondazione Policlinico universitario Campus Bio-Medico
Roma, Italy
Not Yet Recruiting
33
UOC di Endocrinologia, Diabetologia e Andrologia Medica, IRCCS Humanitas Research Hospital
Rozzano, Italy
Not Yet Recruiting
34
Donatello Bone Clinic, Casa di Cura Villa Donatello
Sesto Fiorentino, Italy
Actively Recruiting
35
Dipartimento di Scienze Mediche, Chirurgiche e Neuroscienze, Policlinico Santa Maria delle Scotte, Università di Siena
Siena, Italy
Not Yet Recruiting
36
Endocrinologia Pediatrica Ospedale Infantile regina Margherita-Dipartimento di Scienze di Sanità Pubblica e Pediatriche, Università degli studi di Torino
Torino, Italy
Not Yet Recruiting
37
SCDU Endocrinologia Diabetologia e Malattie del Metabolismo, AOU Città della Salute e della Scienza di Torino, Università di Torino
Torino, Italy
Not Yet Recruiting
38
SCDU Endocrinologia Oncologica, AOU Città della Salute e della Scienza di Torino, Università di Torino
Torino, Italy
Not Yet Recruiting
39
IRCCS Materno-Infantile Burlo Garofolo
Trieste, Italy
Actively Recruiting
40
SOC Endocrinologia, Azienda Sanitaria-Universitaria Friuli Centrale
Udine, Italy
Not Yet Recruiting
41
UOS di Endocrinologia, Policlinico GB Rossi, Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy
Not Yet Recruiting
Research Team
M
Maria Luisa Brandi, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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