Abstract Background/Introduction Romosozumab is an anti-sclerostin antibody approved in Italy as a second-line therapy for fracture-related osteoporosis in postmenopausal women, for up to 12 months. The drug is contraindicated in patients with high cardiovascular risk, while safety data in patients with a history of active or previous neoplasia are still limited. Purpose The aim of the study is to assess the oncological safety of Romosozumab in terms of recurrence, progression and new neoplastic events. Methods This single-center prospective observational study involved patients treated with Romosozumab for at least 6 months from September 2022 to June 2025, with a cancer diagnosis prior to the start of anti-fracture therapy. Results Of the 131 patients treated at our center, 15% (19/131) had a history of cancer. All of them were postmenopausal women, with an average age of 75 years and previous osteoactive treatments. 42% had been treated with zoledronate, 26% with denosumab, 21% with oral bisphosphonates, and 11% with teriparatide. Among the women with cancer, 32% had breast cancer, 32% had reproductive tract tumors, 21% had hematological malignancies; 11% had cutaneous melanoma and 5% had anal cancer. Only one patient with a solid tumor had metastatic disease but was in remission after systemic treatment. All patients with solid tumors had been treated surgically, 53% (8/15) had received radiotherapy, and 60% (9/15) had received systemic treatment. Fifty percent (2/4) of patients with hematological neoplasms had received systemic treatment, while only one patient had also undergone radiotherapy. Twenty-one percent (4/19) are still undergoing active treatment, while 79% (15/19) are undergoing oncological follow-up. During follow-up, 100% of patients showed no disease progression or recurrence, while only one patient had a new cancer diagnosis. In women with cancer, no cardiovascular events or adverse effects were reported. Seventy-nine percent completed the 12-month cycle, while the remaining 21% are still undergoing treatment. Conclusion(s) Although limited, the study suggests that Romosozumab is safe and well tolerated in cancer patients, with no impact on disease progression or recurrence at least in the short term, even in patients undergoing radiation therapy and those with hematological malignancies.
Fanti et al. (Mon,) studied this question.