[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533073":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":11,"studyPopulation":11,"armGroups":43,"interventions":55,"overallOfficials":11,"centralContacts":65,"locations":11,"responsibleParty":75,"collaborators":11,"id":77,"slug":11,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":11,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":11,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":11,"overallStatus":94,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":11},{"fullName":5,"class":6},"Shanghai JMT-Bio Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Time to the First on-study Skeletal-Related Event (SRE)",null,"Up to approximately 48 months",[14,16,19,21,23,25,27],{"measure":15,"description":11,"timeFrame":12},"Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE)",{"measure":17,"description":11,"timeFrame":18},"Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx\u002FCr)","Up to approximately 28 months",{"measure":20,"description":11,"timeFrame":12},"Quality of life score (concise pain assessment Scale and EQ-5D-5L scale);",{"measure":22,"description":11,"timeFrame":12},"Incidence and severity of adverse events (AEs)",{"measure":24,"description":11,"timeFrame":12},"JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab)",{"measure":26,"description":11,"timeFrame":12},"Serum concentration of JMT103",{"measure":28,"description":11,"timeFrame":29},"Overall survival (OS)","Up to approximately 6 years",{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"RANDOMIZED","PARALLEL","multicenter, randomized, double-blind clinical Trail","TREATMENT",{"masking":36,"maskingDescription":37,"whoMasked":38},"QUADRUPLE","Double-blind",[39,40,41,42],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Group 1-JMT103","EXPERIMENTAL","Participants will receive JMT103 and zoledronic acid placebo.",[49],"Drug: JMT103",{"label":51,"type":46,"description":52,"interventionNames":53},"Group 2-zoledronic acid","Participants will receive zoledronic acid and JMT103 placebo.",[54],"Drug: zoledronic acid",[56,61],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":11},"DRUG","JMT103","120 mg by subcutaneous injection every 4 weeks",[45],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":11},"zoledronic acid","4 mg by intravenous drip (100mL:4mg) every 4 weeks",[51],[66,71],{"name":67,"role":68,"phone":69,"phoneExt":11,"email":70},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"name":72,"role":68,"phone":73,"phoneExt":11,"email":74},"Zefei Jiang, M.D","13901372170","jzf_cscobc@csco.org.cn",{"type":76,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100533073",false,"NCT06221072","A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid","A Phase III, Multicenter, Randomized, Double-blind Clinical Trail to Assess JMT103 Compared to Azoledronic Acid for the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age: older than 18 years;\n2. Breast cancer, prostate cancer, lung cancer and other solid tumors diagnosed by histological or cytological examination (prostate patients should also meet: castration-resistant prostate cancer with serum testosterone \\\u003C50 ng\u002FdL or 1.7 nmol\u002FL and serum PSA progression after surgery or drug castration treatment);\n3. Patients with imaging studies showing at least one tumor bone metastasis;\n4. With a good organ function;\n5. Expected survival of at least 6 months.\n\nExclusion Criteria:\n\n1. Previous or ongoing osteomyelitis or osteonecrosis of the jaw; dental or oral surgery; acute dental or jaw disease requiring oral surgery; invasive dental procedures planned during the study; patients with pulpitis during the screening period;\n2. Radiotherapy or surgery for the bone metastases is planned during the study;\n3. Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI\u002FCT examination to exclude patients with brain metastasis);\n4. Patients with bone metabolic diseases \\[e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism\u002Fhypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper\u002Fhypoparathyroidism, etc.\\];\n5. Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (BP\\> 150\u002F90 mmHg after standard therapy), unstable angina, arrhythmia requiring medical or instrumental treatment, history of myocardial infarction within 6 months, echocardiography with left ventricular ejection fraction \\\u003C50%;\n6. Treatment with anti-RANKL antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose;\n7. Patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.).","ALL","18 Years",{"count":86,"type":87},1360,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","This is a phase Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is to determine if JMT103 is non-inferior to zoledronic acid.",[93],"Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors","NOT_YET_RECRUITING","2024-01-14",{"date":97,"type":98},"2024-01-24","ACTUAL",{"date":100,"type":87},"2024-04-05",{"date":102,"type":87},"2028-05-31",{"name":5,"class":6}]