New study aims to prevent bone fractures in liver cancer patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 to 75 years * Hepatocellular carcinoma confirmed by imaging and/or histology according to current institutional diagnostic standards * Bone metastasis confirmed by CT, MRI, bone scintigraphy, PET-CT, or pathology * ECOG performance status 0 to 1 * Child-Pugh class A or stable Child-Pugh B7 judged suitable for systemic treatment * At least 1 measurable intrahepatic lesion at baseline and planned initiation of a PD-1 inhibitor-based systemic therapy * Estimated life expectancy of at least 3 months * Adequate organ function according to protocol-defined laboratory criteria * Corrected serum calcium within the normal range, or corrected to protocol-defined range after calcium/vitamin D supplementation * Completed baseline oral/dental risk assessment and willingness to avoid nonessential invasive dental procedures during the study * Written informed consent and willingness to comply with study visits, questionnaires, sample collection, and follow-up Exclusion Criteria: * Prior treatment with PD-1, PD-L1, CTLA-4, or other immune checkpoint inhibitors * Receipt of denosumab or intravenous/oral bisphosphonates for tumor-related bone disease within 6 months before randomization * Uncorrected hypocalcemia or severe vitamin D deficiency that cannot be corrected promptly * Current or prior osteonecrosis of the jaw, jaw osteomyelitis, or high-risk dental condition requiring near-term extraction, implantation, or other invasive dental procedures that cannot be deferred * Active autoimmune disease or need for systemic immunosuppressive treatment, except for low-risk conditions judged acceptable by the investigator * Life-threatening bone complication within 4 weeks before randomization that is not stabilized, including unresolved spinal cord compression or clinically significant spinal instability * Active infection, including uncontrolled bacterial or fungal infection, active tuberculosis, or other condition judged unsafe for systemic treatment * Symptomatic or uncontrolled central nervous system metastases * Pregnancy or breastfeeding, or refusal to use effective contraception when applicable * Known severe hypersensitivity to denosumab or any study-related treatment component * Another active malignancy, poor compliance, or any condition judged by the investigator to make study participation unsuitable