[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533073":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":40,"collaborators":25,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":25,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":25,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":25,"overallStatus":60,"whyStopped":25,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":25},{"fullName":5,"class":6},"Shanghai JMT-Bio Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1-JMT103","EXPERIMENTAL","Participants will receive JMT103 and zoledronic acid placebo.",[13],"Drug: JMT103",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2-zoledronic acid","Participants will receive zoledronic acid and JMT103 placebo.",[18],"Drug: zoledronic acid",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","JMT103","120 mg by subcutaneous injection every 4 weeks",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"zoledronic acid","4 mg by intravenous drip (100mL:4mg) every 4 weeks",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Zefei Jiang, M.D","13901372170","jzf_cscobc@csco.org.cn",{"type":41,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100533073","phase-3-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-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":52,"type":53},1360,"ESTIMATED","INTERVENTIONAL",[56],"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.",[59],"Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors","NOT_YET_RECRUITING","2024-01-14",{"date":63,"type":64},"2024-01-24","ACTUAL",{"date":66,"type":53},"2024-04-05",{"date":68,"type":53},"2028-05-31",{"name":5,"class":6}]