Safety of Romosozumab in women with cancer and osteoporosis at high risk of fractures.

purposeRomosozumab is an anti-sclerostin antibody approved as a second-line therapy for post-menopausal osteoporosis complicated by fractures. 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.

methodsThis single-center prospective observational study involved patients treated with romosozumab for at least 6 months from June 2023 to June 2025, with a cancer diagnosis prior to the start of anti-fracture therapy.

resultsOf the 131 patients treated at our center, 15% (19/131) had a history of cancer. All of them were postmenopausal women (median age 74 years, range 52–82) and had received previous treatments with bone active drugs (42% of patients had been treated with zoledronate i.v., 26% with denosumab 60 mg/6 months s.c, 21% with oral bisphosphonates, and 11% with teriparatide 20 mcg s.c per day). Among the women with cancer, 32% had breast cancer, 32% had reproductive tract tumors, 21% had hematological malignancies, 11% had cutaneous melanoma and one patient 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 33% (5/15) had received systemic treatment. 50% (2/4) of patients with hematological neoplasms had received systemic treatment, while only one patient had also undergone radiotherapy. 21% (4/19) were still undergoing active oncological treatment at the time of romosozumab therapy, while 79% (15/19) were in regular follow-up (13 patients were in remission, and 2 were managed with a wait-and-see strategy). At the follow-up, 79% of patients completed the 12-month cycle of romosozumab, while the remaining 21% were still undergoing the anti-osteoporotic treatment. During follow-up, 100% of patients showed neither progression or recurrence of oncological disease, while only one patient had a new cancer diagnosis. No cardiovascular events were reported in the study cohort.

conclusionsThe study suggests that romosozumab might be safe and well tolerated in cancer survivors, 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.