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NOT YET RECRUITING
NCT06826664

Institution of an Italian Multicenter Database of Patients Affected by Diseases of Phosphate Metabolism

Sponsor: F.I.R.M.O. - Fondazione Italiana Ricerca sulle Malattie dell'Osso - Ente del Terzo Settore

View on ClinicalTrials.gov

Summary

The goal of this observational study is to create, manage and analyze a multicenter national database of patients affected by diseases of phosphate metabolism, aimed at collecting and studying anamnestic, diagnostic, genetic, clinical, and therapeutic data in a relatively wide number of patients with these rare inherited metabolic disorders in Italy. The study will include 28 specialist clinical centers of endocrinology, pediatric endocrinology, and pediatrics, 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 each disease and the less common ones, with the final goal of refining and deepening medical knowledge in the field of these rare inherited metabolic disorders, and, thus, to be able to define optimal tailored diagnostic, 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 diseases of phosphate metabolism in Italy, globally and for single different disorders 2. Clinical and biochemical characterization of different diseases of phosphate metabolism (according to single disorders and different genetic base), through both cross-sectional and longitudinal analyses of collected data 3. Evaluation of skeletal health and bone fragility in patients with diseases of phosphate metabolism, globally and based on single phosphate metabolism disorder, gender, and age 4. Self-evaluation of health-related quality of life in patients with a disease of phosphate metabolism 5. Over time evaluation of responses to therapies in patients with diseases of phosphate metabolism. The study will include a single cohort of female and male patients of any age, affected by a disease of phosphate metabolism. 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. Therapies for which response outcomes will be collected in the database, are those commonly employed for the treatment of diseases of phosphate metabolism, regardless of patients' inclusion in this observational study.

Official title: Creation, Management and Analysis of a National Database of Patients Affected by Diseases of Phosphate Metabolism

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-06-01

Completion Date

2035-05-31

Last Updated

2025-02-14

Healthy Volunteers

No

Locations (28)

U.O.C. Endocrinologia, Azienda Ospedaliero Universitaria Policlinico Consorziale, Università degli Studi di Bari "Aldo Moro"

Bari, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna, UO Pediatria, Programma di Malattie Endocrino-Metaboliche

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

Clinica Endocrinologica, Dipartimento di Medicina Interna e Specialità Mediche (DiMI), IRCCS Ospedale Policlinico San Martino, Università di Genova

Genova, Italy

Clinica Pediatrica ed Endocrinologia, 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

Dipartimento di Pediatria, IRCCS Ospedale San Raffaele

Milan, Italy

SC Endocrinologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Dipartimento di Pediatria, Azienda Universitaria Ospedaliera della Seconda Università degli Studi di Napoli

Naples, Italy

Clinica Medica 1, Dipartimento di Medicina, Università di Padova

Padova, Italy

UOC Endocrinologia, DIMED, Azienda Ospedaliero-Universitaria di Padova

Padova, Italy

Centro di Riferimento Regionale Toscano per l'Endocrinologia Pediatrica, Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Unità Operativa Endocrinologia 2, Azienda Ospedaliera Universitaria Pisana

Pisa, 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

Donatello Bone Clinic, Casa di Cura Villa Donatello

Sesto Fiorentino, 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

IRCCS Materno-Infantile Burlo Garofolo

Trieste, Italy

SOC Endocrinologia, Azienda Sanitaria-Universitaria Friuli Centrale

Udine, Italy

Unità di Reumatologia, Dipartimento di Medicina, Università di Verona

Verona, Italy