[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteogenesis-imperfecta-oi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteogenesis-imperfecta-oi":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,69,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100635804","phase-2-a-dose-regimen-finding-study-of-aga2115-in-chinese-patients-with-osteogenesis-imperfecta-eir-100635804",false,"NCT07557446","A Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR)","A Phase 2 Multi-center, Randomized, Open-Label, Dose Regimen-Finding Study of AGA2115 in Chinese Adults and Adolescents With Type I, III, or IV Osteogenesis Imperfecta","EIR","Inclusion Criteria:\n\n* Adults (18-75 years) or adolescents (12-17 years) with a confirmed diagnosis of Osteogenesis Imperfecta (OI) Type I, III, or IV with genetic confirmation of pathogenic variants in COL1A1 or COL1A2 genes\n* BMD T-score of ≤-1.0 at the lumbar spine, total hip, or femoral neck (adults) or BMD Z-score of ≤-1.0 at the lumbar spine, total hip, or femoral neck (adolescents)\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n\nExclusion Criteria:\n\n* Vitamin D deficiency\n* Concomitant uncontrolled diseases or conditions that could affect bone metabolism such as hypo-\u002Fhyperparathyroidism, hypo-\u002Fhyperthyroidism, abnormal thyroid function or thyroid disease, or other endocrine disorders.\n* Current hyper- or hypocalcemia.\n* History of rickets, osteomalacia, or other significant skeletal disorders (excluding OI) leading to long-bone deformities and\u002For increased risk of fractures.\n* Use of bisphosphonates within the past 6 months.\n* Use of teriparatide, abaloparatide, strontium ranelate, or hormone replacement therapy within the past 12 months.\n* Use of denosumab (or denosumab biosimilars) within the past 2 years.\n* Use of anti-sclerostin antibody medications (romosozumab, setrusumab, blosozumab) at any time.\n* History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant) within the past 12 months.\n* Malignancy within the last 5 years.\n* Pregnant or breastfeeding women, or women planning to become pregnant during the study or within 4 months after the last dose of IP.","ALL","12 Years","75 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is to evaluate the safety and efficacy of AGA2115 at three different dose regimens in Chinese adults and adolescents with Type I, III, or IV Osteogenesis imperfecta (OI).",[28],"Osteogenesis Imperfecta (OI)",[30,31,32],"Osteogenesis Imperfecta","dose regimen finding","Phase 2","RECRUITING","2026-06-17",{"date":36,"type":37},"2026-06-22","ACTUAL",{"date":39,"type":22},"2026-06",{"date":41,"type":22},"2029-07",{"name":43,"class":44},"Angitia Biopharmaceuticals Guangzhou Limited","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100597753","phase-2-osteogenesis-imperfecta-trial-of-aga2115-for-adults-with-col1a1-andor-col1a2-genetic-variations-idun-100597753","NCT07062588","Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and\u002For COL1A2 GeNetic Variations (IDUN)","A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of AGA2115 in Adults With Type I, III, or IV Osteogenesis Imperfecta (OI)","IDUN","Inclusion Criteria:\n\n* Male or female adults (aged 18 to 75 years inclusive) with a clinical diagnosis of osteogenesis imperfecta Type I, III, or IV with documented genetic testing confirmation of genetic variations in the COL1A1 or COL1A2 genes\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n* BMD T-score of ≤ -1.0 at the lumbar spine, total hip, or femoral neck\n\nExclusion Criteria:\n\n* Vitamin D deficiency\n* Concomitant uncontrolled diseases or conditions that could affect bone metabolism such as hypo-\u002Fhyperparathyroidism, hypo-\u002Fhyperthyroidism, abnormal thyroid function or thyroid disease, or other endocrine disorders\n* Current hyper- or hypocalcemia\n* History of rickets or osteomalacia or any skeletal condition (other than OI) leading to long-bone deformities and\u002For increased risk of fractures\n* Treatment with bisphosphonates within the past 6 months\n* Treatment with teriparatide, abaloparatide, strontium ranelate, or hormone replacement therapy within the past 12 months\n* Treatment with denosumab (or denosumab biosimilars) within the past 2 years\n* Treatment with anti-sclerostin antibody medications (romosozumab, setrusumab, blosozumab) at any time\n* History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant) within the past 12 months\n* Malignancy within the last 5 years\n* Pregnant or breastfeeding women, or women planning to become pregnant during the study\n* Participation in any clinical study within the past 12 months during which the participant was administered any IP (participant must also agree not to enroll in any other clinical study concurrently in which IP is administered)","18 Years",{"count":55,"type":22},80,[25],"This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.",[28],"2026-05-28",{"date":61,"type":37},"2026-05-29",{"date":63,"type":37},"2025-12-12",{"date":65,"type":22},"2029-02",{"name":67,"class":44},"Angitia Incorporated Limited",27,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100615026","prospective-observational-cohort-study-of-cardiac-structure-and-function-in-children-and-adults-with-osteogenesis-imperfecta-100615026","NCT07287241","Prospective Observational Cohort Study of Cardiac Structure and Function in Children and Adults With Osteogenesis Imperfecta","Evaluation of Cardiac Function and Morphology in Individuals With Osteogenesis Imperfecta: Prospective Observational Study","OI Cardio","Inclusion Criteria:\n\n* Diagnosis of OI according to the modified Sillence classification (Mortier et al., 2019)\n* All subjects with OI who attend genetic consultations at the clinic affiliated with the Rare Skeletal Diseases Unit of the IRCCS Rizzoli Orthopaedic Institute (IOR)\n* Willingness to undergo clinical and instrumental assessments at the IOR\n\nExclusion Criteria:\n\n* Acute upper and\u002For lower respiratory tract infections at the time of assessment\n* Cognitive impairment affecting cooperation and the performance of examinations","5 Years","80 Years",{"count":80,"type":22},40,"OBSERVATIONAL","This prospective observational investigation will examine the incidence and progression of cardiologic findings in individuals with OI across different age groups. Cardiopulmonary complications are recognized as major contributors to morbidity and mortality in adults with OI, although life expectancy has significantly improved in recent years due to medical advancements.\n\nBy systematically evaluating cardiovascular involvement in this population, the study aims to generate clinically relevant evidence to inform early cardiologic screening strategies and support the development of harmonized and targeted management approaches, ultimately improving clinical practice and the quality of life of individuals living with OI.",[28,30],[30,85,86,87,88],"Bone Diseases","Musculoskeletal Diseases","Genetic Diseases","Observational Study","2025-12-16",{"date":91,"type":37},"2025-12-17",{"date":93,"type":37},"2025-06-10",{"date":95,"type":22},"2031-12",{"name":97,"class":98},"Istituto Ortopedico Rizzoli","OTHER",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100583272","social-cognition-in-dystrophinopathies-and-neurodevelopmental-disorders-100583272","NCT06874166","Social Cognition in Dystrophinopathies and Neurodevelopmental Disorders","Social Cognition in Dystrophinopathies and Neurodevelopmental Disorders. Behavioural and Psychophisiological Measures","Inclusion Criteria:\n\n* Patients diagnosed with Duchenne and Becker muscular dystrophy (genetic and histological diagnosis and clinical diagnosis) (ambulant and non-ambulant).\n* Patients diagnosed with osteogenesis imperfecta.\n* Control group: participants without any neurological or psychiatric disorder\n\nExclusion Criteria:\n\n* presence of comorbid diagnoses,\n* sensory deficit\n* specific condition that could prevent the application of the tests and tasks under study, such as: a) the need for PEG; b) the need for tracheostomy; c) the need for assisted ventilation.\n* cognitive level lower than 60.",true,"MALE","4 Years",{"count":111,"type":22},45,"The primary aim of this observational study is to investigate specific aspects of social cognition in dystrophinopathies. Body awareness, interpersonal distance and emotional processing will be measured in a sample of patients affected by Becker (BMD) and Duchenne (DMD) muscular dystrophy, compared with a sample of patients affected by osteogenesis imperfecta (OI), and both compared with a control sample with typical development.\n\nThe secondary aim is to study cortical activity at rest, by means of electroencephalography (EEG), to explore frequencies and time course of EEG responses. Moreover, the relationship between EEG activity and neuropsychological, dispositional and subjective measures will be explored through correlational analyses.",[114,28,115],"Duchenne \u002F Becker Muscular Dystrophy","Social Cognition",[115,117,28,118,119,120],"Duchenne \u002F Becker muscular dystrophy","EEG","Interpersonal distance","Interoception","NOT_YET_RECRUITING","2025-03-11",{"date":124,"type":37},"2025-03-13",{"date":126,"type":22},"2025-09",{"date":128,"type":22},"2027-12",{"name":130,"class":98},"IRCCS Eugenio Medea"]