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  • A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis

    This is a 12-month, multicentre, open-label, non-randomized, interventional single-arm study to assess the course of synovial hypertrophy in previously treated patients ≥12 years of age with moderate or severe haemophilia A achieving high sustained FVIII levels provided by weekly efanesoctocog alfa prophylaxis. To be eligible to enroll in the study, patients must have existing synovial hypertrophy in at least one of the 6 index joints (ankles, elbows, and knees) as assessed by the HEAD-US scoring system. A retrospective data collection on patients' haemophilia, medical, and surgical history will be performed, including a 12-month history of previous treatment and treated bleeding episodes. The study will start with the Screening Visit, which can be conducted up to 45 days prior to the Baseline Visit (Day 1), to check whether the patient fulfils all the inclusion criteria and none of the exclusion criteria. Patients will have an ultrasound examination of all non-prosthetic index joints at screening. The ultrasound images will be sent for central reading assessment using the HEAD-US scoring system to determine whether the patient has at least one eligible joint required for study inclusion. Once it is confirmed that a patient is eligible for inclusion, he/she will be enrolled in the study and attend a mix of on-site visits and phone call visits. The results from central reading assessment will be sent to the study sites and included in the baseline characteristics of the patients. MRI examinations can be conducted at the Baseline Visit or up to 28 days afterwards. Images from MRI will also be sent for central reading assessment using the International Prophylaxis Study Group (IPSG) MRI scale. The central reading assessment will be sent to the study sites and included in the patient data. Patients will be treated with once-weekly efanesoctocog alfa (50 IU/kg) prophylaxis and will complete the patient diary with their dosing and bleeding information. Assessments will be conducted during the on-site visits, which will occur every 6 months, and during phone call visits, which will occur halfway between these visits. A Safety Follow-up Call will be conducted 14 (+7) days after the End of Treatment (EoT) Visit. Ultrasound and MRI will be used to detect changes in synovial hypertrophy in index joints of patients. The primary endpoint of improvement in existing synovial hypertrophy from baseline to Month 12 as well as the key secondary endpoint of detection of new synovial hypertrophy and change in joint health status from baseline to Month 6 or Month 12 will be assessed using ultrasound and the HEAD-US scoring system. To obtain 100 eligible index joints, the target is to enroll approximately 35 patients.

    Phase

    4

    Span

    106 weeks

    Sponsor

    Swedish Orphan Biovitrum

    Rozzano

    Recruiting

  • Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

    The PALMARES-2 study aims to collect data from different sources, i.e. real-world clinical data, medical images and biological data and samples, from patients treated with CDK4/6i as first-line therapy for patients with HR+/HER2- advanced breast cancer. Due to the complexity of the data collected and the different objectives of the study, this protocol includes several sub-studies, which include different methodologies for data collection, extraction and analysis: - The first sub-study (RWD sub-study) will aim to collect real-world clinical data of patients who received ET+CDK4/6i in the first-line setting; the primary objective of this sub-study is to assess whether there is a difference in OS between the three CDK4/6i in the real-world population, while secondary objectives include comparisons in specific sub-groups; - The second sub-study (Safety sub-study) includes the collection of comorbidities, concomitant medications and toxicities of patients enrolled in the study; the primary objective of this sub-study is to evaluate the difference in severe toxicity between the three CDK4/6i in the real-world population - The third sub-study (medical imaging sub-study) consists of the collection of computed tomography (CT) and fluorodeoxyglucose positron emission tomography (FdG-PET) images at baseline and digitised haematoxylin-eosin (HE) slides to build a multi-omics predictive model; - The fourth sub-study (translational sub-study) aims to collect tumour samples from a proportion of patients enrolled in the study to perform genomics and transcriptomics analyses; information from this data source will be integrated into the model built with the previous data to further improve the performance of the previous model - The fifth sub-study (subsequent lines sub-study) focuses on the lines of treatment administered to patients enrolled in the study at the time of progression after first-line treatment with ET+CDK4/6i, with the aim of building predictive models of response to subsequent lines of treatment, capable of supporting oncologists' and patients' decisions in this context.

    Phase

    N/A

    Span

    922 weeks

    Sponsor

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    Rozzano

    Recruiting

  • A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

    The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm. This study will be conducted at up to 200-250 sites globally in approximately 25 countries.

    Phase

    3

    Span

    298 weeks

    Sponsor

    AstraZeneca

    Rozzano

    Recruiting

  • A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma

    A Phase II open-label, randomised, parallel-arm study, which will assess the clinical efficacy of oral roginolisib (IOA 244 [roginolisib hemi-fumarate]) as monotherapy against a control of Investigator´s treatment choice in patients with advanced or metastatic uveal melanoma (UM). This study will enrol approximately 85 male and female patients aged over 18 years with advanced or metastatic UM, who have progressed following at least 1 prior immunotherapy treatment. The disease must be measurable (i.e., at least 1 measurable lesion) as per RECIST v1.1 by Computerised Tomography (CT) scan or Magnetic Resonance Imaging (MRI).

    Phase

    2

    Span

    201 weeks

    Sponsor

    iOnctura

    Rozzano

    Recruiting

  • Neurosurgical Outcome Network

    The evaluation of outcome indicators, quality of life, and complexity in Neurosurgery has gained significant importance not only at a clinical and therapeutic level but also as a tool to assess the effectiveness and efficiency of the healthcare system. This study aims to evaluate neurosurgical outcomes and their predictors using measures shared among participating centers. Such evaluation varies from center to center, and the predictive factors are not entirely known or shared. Standardizing the evaluation of outcomes and predictors improves research quality, enables data comparison, and fosters a common language in everyday clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical pathologies. Primary Objective: Collect and describe the pre- and postoperative clinical, cognitive, and psychological status in various neurosurgical pathologies. Secondary Objectives: Identify outcome predictors. Primary Endpoint: Description of pre- and postoperative clinical, cognitive, and psychological data of patients undergoing neurosurgical intervention. Secondary Endpoints: Analyze the association between preoperative indicators collected and postoperative outcomes. Specific predictors and outcome measures for each neurosurgical pathology will be considered and reported in Appendix 1. Patient enrollment from Neurosurgery Departments; collection of clinical, cognitive, and psychological data before the intervention and during follow-up after the intervention (timing varies depending on the neurosurgical pathology); data analysis through AI. For all neurosurgical pathologies, the following data will be collected: sociodemographic, clinical (Charlson Comorbidity Index, heart disease, diabetes, Chronic Obstructive Pulmonary Disease, hypertension, Body Mass Index, smoking, psychiatric pathology, admission date, intervention date, discharge date, Modified Rankin Scale, American Society of Anesthesiologists, weight, height), anesthesiological (collected only by FINCB), and complication-related data (Novel Therapy-Disability-Neurology).

    Phase

    N/A

    Span

    239 weeks

    Sponsor

    Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    Rozzano

    Recruiting

  • Volrustomig Priming Regimens Exploratory Phase II Platform Study

    This is a platform, randomized, open-label, multicenter, global study. Enrolled participants with Stage IV non-squamous non-small cell lung cancer (NSQ NSCLC) who are treatment-naïve and have not received previous treatment for advanced or metastatic disease. These participants will be randomized in a 1:1 ratio to one of the two treatment arms: Arm 1A and Arm 1B. Both arms will test a volrustomig dosing in combination with chemotherapy.

    Phase

    2

    Span

    149 weeks

    Sponsor

    AstraZeneca

    Rozzano

    Recruiting

  • A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors

    Phase

    1

    Span

    127 weeks

    Sponsor

    BeiGene

    Rozzano

    Recruiting

  • A Phase 1b Trial to Evaluate Safety of MB097 in Combination with Pembrolizumab in Melanoma Patients

    Phase

    1

    Span

    157 weeks

    Sponsor

    Microbiotica Ltd

    Rozzano

    Recruiting

  • Institution of an Italian Multicenter Database of Patients with Parathyroid Carcinoma or Atypical Parathyroid Adenoma

    A. Background and rationale: Parathyroid carcinoma (PC) and atypical parathyroid adenoma (aPA) are two extremely rare forms of cancer of the parathyroid glands, that represent approximately 1% of all parathyroid tumors. The extreme rarity of these two types of tumor results in a lack of specific and detailed clinical information on them. This, together with the current scarcity and incompleteness of multicenter and prospective studies on large case series, has not yet allowed to reach a shared consensus for the clinical and therapeutic management and follow-up of these tumors, nor the creation of specific guidelines. For this reason, the institution and management of national multicenter databases of patients with parathyroid carcinoma or atypical parathyroid adenoma are extremely important to allow the collection of a relatively high number of patients with these two endocrine cancers, whose clinical features could be, then, carefully studied in every aspect of the disease, from the most classic traits of the pathology to the less common ones, in both retrospective and prospective manners. B. Main aim and specific objectives: Main goal of this observational study is to create, manage and analyze a retro-prospective multicenter national database of patients with parathyroid carcinoma or atypical parathyroid adenoma in Italy, aimed at collecting and studying anamnestic, diagnostic, genetic, clinical, histological, and therapeutic data on these two extremely rare parathyroid cancers in a relatively wide number of patients. Such a database will allow for an epidemiological evaluation of the prevalence and incidence of parathyroid carcinoma and atypical parathyroid adenoma in Italy, and to collect case history of patients whose clinical cases will be studied in detail and followed over time up to 10 years after the recruitment in the study, also as post-operative follow-up, in order to refine knowledge in the field of these two rare and malignant parathyroid tumors, to identify the most effective therapy, and direct future research in the identification of possible specific therapeutic targets. Specific objectives of the studies are: 1. Creation of an Italian centralized multicenter database of patients with parathyroid carcinoma or atypical parathyroid adenoma, through the collection of patients at 33 specialist clinical centers of endocrinology and endocrine surgery, located throughout the Italian territory and visiting patients from all the 20 regions of Italy. 2. Collection of a relatively high number of patients with parathyroid carcinoma or atypical parathyroid adenoma, both as sporadic tumors or in the context of genetic disorders. 3. Retrospective collection of data about past clinical history of parathyroid carcinoma and atypical parathyroid adenoma, at the time of the recruiting visit. 4. Continuous and updated prospective collection of patients' data over time, starting from the first recruiting visit up to 10 years after the recruitment in the study. 5. Evaluation of the prevalence and incidence of parathyroid carcinoma and atypical parathyroid adenoma in Italy, both as sporadic disease or in the context of genetic disorders. 6. Clinical, histological and biochemical characterization of parathyroid carcinoma vs atypical parathyroid adenoma, to assess features and aspects that distinguish these two kinds of tumors and may help in the differential diagnosis. 7. Evaluation of short-term and long-term response to therapies in patients with parathyroid carcinoma and in patients with atypical parathyroid adenoma to assess possible differences between these two types of cancer and, thus, to design tailored clinical and therapeutic managements for patients. 8. Evaluation of short-term and long-term response to therapies in sporadic forms vs genetic forms of parathyroid carcinoma and atypical parathyroid adenoma, to assess possible differences between these two different forms of diseases and, thus, to design tailored clinical and therapeutic managements for patients. C. Study population: The study will include two independent cohorts of female and male patients of any age, one including patients who developed parathyroid carcinoma (cohort 1) and one including patients who developed atypical parathyroid adenoma (cohort 2), both as sporadic cancer or in the context of genetic diseases. The study does not include either any control group/comparison group or healthy volunteers. Given the extreme rarity of parathyroid carcinoma and atypical parathyroid adenoma, we estimate that we will be able to include in the study a minimum of 100 and a maximum of 300 patients affected by parathyroid carcinoma or atypical parathyroid adenoma during the 10 years of the study. Inclusion criteria - Cohort 1: parathyroid carcinoma - Cohort 2: atypical parathyroid adenoma Exclusion criteria - None D. Study design and setting: Non-profit, multicenter, national, retro-prospective, observational study, consisting in the design, creation, management and analysis of an Italian database of patients with parathyroid carcinoma or atypical parathyroid adenoma. The study will last 10 years. The enrollment of patients with parathyroid carcinoma or atypical parathyroid adenoma, the inclusion in the database with retrospective collection of their clinical data, and the subsequent prospective collection of clinical follow-up data will take place throughout the duration of the study. For the retrospective collection, retrospective data on parathyroid carcinoma or atypical parathyroid adenoma will be retrieved from patient's medical records, at the time of the medical visit that the patient will carry out at the Clinical Center for the evaluation of his/her parathyroid disease, regardless of inclusion in this study. Prospective data relating to the tumor follow-up will be collected during the subsequent medical follow-up visits, scheduled for each patient as part of the clinical management of his/her parathyroid disease, regardless of inclusion in this study. Being an observational study, this study itself does not involve the administration of any drug, nor the use of any medical device, nor does it involve additional medical visits, clinical analyses or care procedures in addition to those conventionally scheduled for the clinical and therapeutic management of patient affected by parathyroid carcinoma or atypical parathyroid adenoma. No participant biospecimens of any type will be collected and retained to perform this study. Pharmacological treatments and parathyroid surgery, for which data on response to therapy and peri-operative and post-operative outcomes will be collected in the database during the study, are those that are conventionally administered and performed in patients with parathyroid carcinoma or atypical parathyroid adenoma in the context of treatment of their pathology, regardless of their inclusion in this observational study. All data will be collected anonymously, and they will be analyzed as aggregates. Data collected in the database will be, first, processed using descriptive statistics, such as frequency tables for categorical data, median and quartiles for quantitative data on ordinal scales and mean and standard deviation for quantitative data on metric scales. Secondly, the correlations between variables will be evaluated using the Pearson correlation index in the case of continuous variables and the chi-square test for categorical variables. E. Data and variables: Data collected in the database will include (if available in patient's medical records): - Demographics (sex, year of birth) - Family history of parathyroid carcinoma/atypical parathyroid adenoma or other parathyroid diseases in first-degree relatives - Lifestyle habits (i.e smoke, alcohol intake) - History of neck irradiation - Clinical history and therapy of hyperparathyroidism prior to diagnosis of parathyroid carcinoma/atypical parathyroid adenoma - Presence of comorbidities - Age at diagnosis of parathyroid carcinoma/atypical parathyroid adenoma, type of diagnosis, genetic test (if performed) - Clinical manifestations of parathyroid carcinoma/atypical parathyroid adenoma (i.e hypercalcemia, nephrolithiasis, nephrocalcinosis, bone mass loss, fragility fracture, bone pain, radiological findings of skeletal complaints, gastrointestinal manifestations) - Pre-operative instrumental screening of the neck (neck ultrasounds, parathyroid scintigraphy with 99mTc-Sestamibi, neck CT scan, 11C-choline PET/CT, 11C-methionin PET/CT, 18F-FDG-PET/CT) - Pre-operative biochemical measurements of parameters of parathyroid function and of bone and mineral metabolism - Pre-operative DXA evaluation of bone status - Pre-operative identification of lymph node and/or distant metastases - Pharmacological therapies - Surgical intervention (age, type, clear margins, removed lymph nodes, complications, perioperative mortality, etc) - Post-operative histological analysis of resected tumor (surrounding tissue and vascular invasion, Ki67 index, mitotic activity, nuclear atypia, aneuploidy, immunostaining of parafibromin and other specific proteins) - TMN tumor staging - Somatic genetic screening of resected tumor - Post-operative clinical follow-up (serum calcium normalization, post-operative hypoparathyroidism, episodes of hypocalcemia, episodes of hypophosphatemia, hungry bone syndrome, disease persistence, tumor recurrence, etc) - Post-operative biochemical measurements of parameters of parathyroid function and of bone and mineral metabolism (the first check-up after parathyroid surgery, and subsequent follow-up measurements) - Post-operative instrumental screening of the neck (neck ultrasounds, parathyroid scintigraphy with 99mTc-Sestamibi, neck CT scan, 11C-choline PET/CT, 11C-methionin PET/CT, 18F-FDG-PET/CT) - Post-operative DXA evaluation of bone status - Death as a consequence of carcinoma/atypical parathyroid adenoma (age of death, cause)

    Phase

    N/A

    Span

    522 weeks

    Sponsor

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

    Rozzano

    Recruiting

  • Institution of an Italian Multicenter Database of Patients Affected by Hypoparathyroidism or Pseudohypoparathyroidism

    A. Background and rationale: Hypoparathyroidism is a rare endocrine disease characterized by low levels of calcium (hypocalcemia) and high levels of phosphorus (hyperphosphatemia) in the blood, as a result of inappropriately low or completely absent levels of parathyroid hormone (PTH). Data on the global epidemiology of this disease are still incomplete, it is estimated to affect less than 1 case in 200,000 people. Even more incomplete are the national incidence data. Hypoparathyroidism can be acquired or congenital. The most common form of hypoparathyroidism is post-surgical (about 75% of cases), following surgery in the neck region with damage and/or removal of the parathyroid glands. Among other forms of acquired hypoparathyroidism there are, in a much lower percentage, those caused by irradiation of the neck, viral infections with infiltration of the parathyroid tissue (i.e. tuberculosis), metastatic infiltrations, autoimmune diseases, chronic magnesium depletion (malabsorption, alcoholism or malnutrition). Congenital hypoparathyroidism can be caused by germline mutations in various genes, which regulate the correct development and/or functionality of the parathyroid glands and synthesis and release of PTH, and can arise as an isolated or syndromic form, the latter in association with other endocrine and non-endocrine alterations. The term pseudohypoparathyroidism, on the other hand, refers to a heterogeneous group of hereditary diseases characterized by resistance to PTH in target organs (proximal tubules of the kidney), which causes hypocalcemia and hyperphosphatemia in the presence of normal and even elevated PTH levels. The real global and Italian prevalence and incidence of hypoparathyroidism and pseudohypoparathyroidism is not certain; the lack of specific national and international registries for this pathology remains a major limitation to its in-depth clinical understanding and to the optimization of the therapeutic management of patients. Implementing and detailing as much as possible the epidemiological, clinical and therapeutic history of hypoparathyroidism, in its various etiological forms, and pseudohypoparathyroidism means not only improving the clinical management of the individual patient, but also allowing for better planning of social, political and health interventions for these pathologies and, overall, improving the quality and life expectancy of patients. For this reason, it is extremely important to create multicenter national databases, such as the one proposed by this study, which allow to collect a relatively high number of patients affected by hypoparathyroidism or pseudohypoparathyroidism, whose cases can be, thus, carefully studied in every aspect, both retrospectively and prospectively. A previous Italian database (HypoparaNET) [1] was established in the period March 2014-September 2015, collecting 509 cases of chronic hypoparathyroidism from 16 Italian Endocrinological Clinical Centers. However, this database collected patients' data limited exclusively to the time of inclusion in the study, not including the collection of follow-up data, and, thus, allowing only an epidemiological evaluation and a cross-sectional observational analysis of the data collected at the time of inclusion in the study. Instead, in the present study, the investigators aim to collect data on hypoparathyroidism and pseudohypoparathyroidism cases over time, allowing not only to analyze epidemiological data and to perform a single shot analysis of collected data, but also to be able to perform longitudinal analyses of the two diseases, with particular attention to the response to therapies. B. Main aim and specific objectives: Main goal of this observational study is to create, manage and analyze a retro-prospective multicenter national database of patients with hypoparathyroidism or pseudohypoparathyroidism in Italy, aimed at collecting and studying anamnestic, diagnostic, genetic, clinical, and therapeutic data on these two endocrine diseases in a relatively wide number of patients. Such a database will allow for an epidemiological evaluation of prevalence and incidence hypoparathyroidism or pseudohypoparathyroidism in Italy, and to collect case history of patients whose clinical cases will be studied in detail and followed over time up to 10 years after the recruitment in the study, in order to refine knowledge in the field of these two rare endocrine diseases. Specific objectives of the studies are: 1. Creation of an Italian centralized multicenter database of patients with hypoparathyroidism or pseudohypoparathyroidism, through the collection of patients at 41 specialist clinical centers of endocrinology, pediatric endocrinology, pediatrics, and endocrine surgery, located throughout the Italian territory and visiting patients from all the 20 regions of Italy. 2. Collection of a relatively high number of patients with hypoparathyroidism of different etiology or with pseudohypoparathyroidism. 3. Retrospective collection of data about hypoparathyroidism or pseudohypoparathyroidism, at the time of the recruiting visit. 4. Continuous and updated prospective collection of patients' data over time, starting from the first recruiting visit up to 10 years after the recruitment in the study. 5. Evaluation of prevalence and incidence of hypoparathyroidism, globally and in its different etiological forms, and of pseudohypoparathyroidism, in Italy. 6. Clinical characterization of different etiological forms of hypoparathyroidism, through both cross-sectional and longitudinal analyses of collected data 7. Clinical characterization of pseudohypoparathyroidism, through both cross-sectional and longitudinal analyses of collected data 8. 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 also based on gender, age, and disease etiology 9. Over time evaluation of response to pharmacological therapies in patients with hypoparathyroidism and pseudohypoparathyroidism. C. Study population: The study will include 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). The study does not include either any control group/comparison group or healthy volunteers. Based on the previous experience with the HypoparaNET database, the investigators can estimate to be able to include in the study at least 600 patients affected by hypoparathyroidism or pseudohypoparathyroidism during the 10 years of the study. Inclusion criteria - Cohort 1: chronic hypoparathyroidism (all etiological forms) - Cohort 2: pseudohypoparathyroidism Exclusion criteria - None D. Study design and setting: Non-profit, multicenter, national, retro-prospective, observational study, consisting in the design, creation, management and analysis of an Italian database of patients with hypoparathyroidism or pseudohypoparathyroidism. The study will last 10 years. The enrollment of patients with hypoparathyroidism or pseudohypoparathyroidism, the inclusion in the database with retrospective collection of their clinical data, and the subsequent prospective collection of clinical follow-up data will take place throughout the duration of the study. For the retrospective collection, retrospective data on hypoparathyroidism or pseudohypoparathyroidism will be retrieved from patient's medical records, at the time of the medical visit that the patient will carry out at the Clinical Center for the evaluation of his/her disease, regardless of inclusion in this study. Prospective data relating to hypoparathyroidism or pseudohypoparathyroidism follow-up will be collected during the subsequent medical follow-up visits, scheduled for each patient as part of the clinical management of his/her clinical condition, regardless of inclusion in this study. Being an observational study, this study itself does not involve the administration of any drug, nor the use of any medical device, nor does it involve additional medical visits, clinical analyses or care procedures in addition to those conventionally scheduled for the clinical and therapeutic management of patient affected by hypoparathyroidism or pseudohypoparathyroidism. No participant biospecimens of any type will be collected and retained to perform this study. Pharmacological treatments for which data on response to therapy will be collected in the database, are those usually administered to patients for the control/treatment of hypoparathyroidism or pseudohypoparathyroidism, regardless of their inclusion in this observational study. All data will be collected anonymously, and they will be analyzed as aggregates. Data collected in the database will be, first, processed using descriptive statistics, such as frequency tables for categorical data, median and quartiles for quantitative data on ordinal scales and mean and standard deviation for quantitative data on metric scales. Secondly, the correlations between variables will be evaluated using the Pearson correlation index in the case of continuous variables and the chi-square test for categorical variables. E. Data and variables: Data collected in the database will include (if available in patient's medical records and part of the normal clinical and therapeutic management of patient regardless of inclusion in this study): - Demographics (sex, year of birth) - Family history of chronic hypoparathyroidism or pseudohypoparathyroidism in first-degree relatives (only for patients with a congenital form of the disease) - History of neck irradiation, viral infections with infiltration of the parathyroid tissue (i.e. tuberculosis), metastatic infiltrations, autoimmune diseases, chronic magnesium depletion, and neck surgery as possible cause of chronic hypoparathyroidism - Presence of comorbidities - Age at diagnosis/onset of hypoparathyroidism or pseudohypoparathyroidism - Genetic testing for congenital forms of hypoparathyroidism or pseudohypoparathyroidism (if performed) - Clinical manifestations of the diseases (i.e paresthesia, cramps, tetany, chondrocalcinosis, nephrocalcinosis, nephrolithiasis, chronic renal failure, ectopic calcifications, neurocognitive and brain disorders, ocular manifestations) - DXA and/or pQCT/HR-pQCT evaluation of bone status - History of fragility fractures - Biochemical measurements of parameters of parathyroid function, bone and mineral metabolism and renal function (at baseline and follow-up visits) - Pharmacological therapies (drug, duration, posology) - Self-evaluation of quality of life (i.e. Questionnaire SF36) - Disease-related morbidity and mortality

    Phase

    N/A

    Span

    522 weeks

    Sponsor

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

    Rozzano

    Recruiting

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