> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-the-prevention-of-bone-related-events-in-728dbe44-ab84-46eb-9bf1-67aa8dd22266 > Record changed: 2026-10-13 # 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 NCT06221072 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) Participants 1,360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) Lead sponsor Shanghai JMT-Bio Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) Start date 2024-04-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) ## Dates **Completion date** 2028-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **First posted** 2024-01-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Registry last updated** 2024-01-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Primary completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Start date** 2024-04-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) ## Size and sites **Participants** 1,360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Planned participants** 1,360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Lead sponsor** Shanghai JMT-Bio Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) ## Identifiers **Registry ID** NCT06221072 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **ClinicalTrials.gov ID** NCT06221072 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Double-blind **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) ## Outcomes ### Primary outcomes 1. Time to the First on-study Skeletal-Related Event (SRE) Timeframe: Up to approximately 48 months ### Secondary outcomes 1. Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE) Timeframe: Up to approximately 48 months 2. Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx/Cr) Timeframe: Up to approximately 28 months 3. Quality of life score (concise pain assessment Scale and EQ-5D-5L scale); Timeframe: Up to approximately 48 months 4. Incidence and severity of adverse events (AEs) Timeframe: Up to approximately 48 months 5. JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab) Timeframe: Up to approximately 48 months 6. Serum concentration of JMT103 Timeframe: Up to approximately 48 months 7. Overall survival (OS) Timeframe: Up to approximately 6 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Age: older than 18 years; 2. 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 <50 ng/dL or 1.7 nmol/L and serum PSA progression after surgery or drug castration treatment); 3. Patients with imaging studies showing at least one tumor bone metastasis; 4. With a good organ function; 5. Expected survival of at least 6 months. ### Exclusion criteria 1. 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; 2. Radiotherapy or surgery for the bone metastases is planned during the study; 3. Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI/CT examination to exclude patients with brain metastasis); 4. Patients with bone metabolic diseases \[e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism/hypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper/hypoparathyroidism, etc.\]; 5. Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (BP> 150/90 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 <50%; 6. Treatment with anti-RANKL antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose; 7. Patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06221072) ## Related records ### Drugs (1) - [Zoledronic acid](https://trialight.com/data/asset/zoledronic-acid-8195ab00-ee9f-4a85-bff4-7c54021686be.md) ### Lead sponsors (1) - [Shanghai JMT-Bio Inc.](https://trialight.com/data/company/shanghai-jmt-bio-inc-b2cc36d1-7731-4e40-acac-4f4564462800.md) ### Targets (1) - [FDPS](https://trialight.com/data/target/fdps-e920be0d-c725-5b45-9825-9717c90813a4.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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