Safety of Romosozumab in Women With Cancer and Osteoporosis at High Risk of Fractures

Strategic Insights -

Researchers from Humanitas University in Milan, Italy have conducted a prospective observational study to evaluate the safety of romosozumab in women with cancer and osteoporosis, who are at high risk of fractures. The study involved 131 patients, with 19% having a history of cancer. The results showed that romosozumab was well tolerated in patients with cancer, with no impact on disease progression or recurrence at least in the short term.

Key Takeaways:

  • The study involved 131 patients treated with romosozumab for at least 6 months, with a cancer diagnosis prior to the start of anti-fracture therapy.
  • 15% of patients (19/131) had a history of cancer, with 32% having breast cancer, 32% having reproductive tract tumors, 21% having hematological malignancies, 11% having cutaneous melanoma, and 6% having other types of cancer.
  • All patients with solid tumors had been treated surgically, with 53% (8/15) receiving radiotherapy, and 33% (5/15) receiving systemic treatment.
  • None of the patients showed progression or recurrence of oncological disease during follow-up, while only one patient had a new cancer diagnosis.
  • Romosozumab was contraindicated in patients with high cardiovascular risk, while safety data in patients with a history of active or previous neoplasia are still limited.

Statistics:

  • 100% of patients showed no progression or recurrence of oncological disease during follow-up.
  • 21% of patients were still undergoing active oncological treatment at the time of romosozumab therapy, while 79% were in regular follow-up.
  • 79% of patients completed the 12-month cycle of romosozumab, while the remaining 21% were still undergoing the anti-osteoporotic treatment.
  • No cardiovascular events were reported in the study cohort.

Sources:

  • Safety of Romosozumab In Women With Cancer and Osteoporosis At High Risk of Fractures (Endocrine, 2025)
  • Humanitas University (Dept. of Biomedical Sciences, Milan, Italy)
  • Springer (www.springer.com)
  • NewsRx LLC (Immunotherapy Weekly, October 15, 2025, p 1022)