Researchers from France have reported that patients with bone metastases who are treated with denosumab have a greater reduction in urinary N-telopeptide and fewer skeletal-related events than patients continuing to receive bisphosphonates. The details of this study appeared in the April 1, 2009 issue of the Journal of Clinical Oncology.[1]

Denosumab is a fully human monoclonal antibody that specifically targets the receptor activator of nuclear factor kappa B ligand (RANKL), a key mediator of the resorptive phase of bone remodeling. Denosumab is being studied across a range of conditions, including osteoporosis, treatment-induced bone loss, rheumatoid arthritis, bone metastases, and multiple myeloma. A biologics license application (BLA) has recently been submitted to the U.S. Food and Drug Administration for denosumab to be used in the treatment and prevention of postmenopausal osteoporosis in women and treatment and prevention of bone loss among patients undergoing hormone ablation for breast or prostate cancer.

This study involved 111 patients with bone metastases from prostate, breast, and other cancers with elevated urinary N-telopeptide levels despite intravenous bisphosphonate therapy. Patients were randomly allocated to continue bisphosphonate therapy or receive denosumab. Seventy-one percent of patients in the denosumab arm had normalization of N-telopeptide levels compared with 29% in the bisphosphonate group. At 25 weeks 64% of patients in the denosumab group maintained a lower N-telopeptide level compared with 37% in the bisphosphonate arm. The incidence of skeletal-related events was 8% in the N-telopeptide group compared with 17% in the bisphosphonate group.

Comments: This study suggests that denosumab is of greater benefit than bisphosphonates in patients with metastases to bone from prostate and other cancers.

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