Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-31 @ 11:29 AM
Study NCT ID:
NCT06344650
Status:
RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify the rate of morphometric vertebral fractures in acromegalic patients', 'timeFrame': '18 months', 'description': 'Identify the rate of morphometric vertebral fractures in acromegalic patients 18 months after hospitalization for neurosurgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'descriptionModule': {'briefSummary': 'Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acromegaly patients able to sign informed consent', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis of acromegaly\n* availability to carry out outpatient checks\n* ability to provide informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* use of glucocorticoids (except those in use for replacement therapy)\n* alcohol abuse\n* exacerbation of chronic disease\n* serious comorbidities (renal or hepatic failure, heart attack, stroke)\n* terminally ill, prolonged immobilization (\\>1 week)\n* clinically evident fracture within the previous six months\n* any other cause of secondary osteoporosis within the last five years\n* any prolonged treatment with drugs with documented influence on bone metabolism during the previous 12 months, including treatment with antiresorptive or anabolic compounds for osteoporosis.'}, 'identificationModule': {'nctId': 'NCT06344650', 'briefTitle': 'Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study', 'orgStudyIdInfo': {'id': 'RF-2021-12373584'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sample', 'type': 'PROCEDURE', 'description': 'Collection of blood serum for molecular and biochemical tests'}, {'name': 'Radiological tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Performance of radiological tests (DXA, VFA, TBS, BSi, HR-pQCT) and DXA morphometry'}, {'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Compilation of questionnaires (AcroQol, SF-36)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriela Felipe', 'role': 'CONTACT', 'email': 'felipe.gabriela@hsr.it', 'phone': '0226435062'}], 'facility': 'Andrea Giustina', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Stefano Frara, MD', 'role': 'CONTACT', 'email': 'frara.stefano@hsr.it', 'phone': '+390226435136'}, {'name': 'Gabriela Felipe, Nurse', 'role': 'CONTACT', 'email': 'felipe.gabriela@hsr.it', 'phone': '+390226435136'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Policlinico Universitario Campus Bio-Medico', 'class': 'OTHER'}, {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Endocrinology', 'investigatorFullName': 'Andrea Giustina', 'investigatorAffiliation': 'IRCCS Ospedale San Raffaele'}}}}