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Denosumab May Benefit Patients with Bone Metastases

In patients who fail bisphosphonate therapy, denosumab helps normalize urinary N-telopeptide levels

TUESDAY, Feb. 24 (HealthDay News) -- In patients with bone metastases from prostate, breast or other cancers, who have elevated urinary N-telopeptide levels despite ongoing intravenous bisphosphonate therapy, treatment with denosumab may be more effective at normalizing levels and reducing skeletal-related events than continuation of bisphosphonate therapy, according to a report published in the Mar. 1 issue of the Journal of Clinical Oncology.

Karim Fizazi, M.D., of the University of Paris in France, and colleagues randomly assigned 111 patients to continue bisphosphonate therapy every four weeks or to receive subcutaneous denosumab at a dose of 180 mg every four weeks or every 12 weeks.

After 13 weeks, the researchers found that the denosumab arms were significantly more likely than the bisphosphonate arm to achieve normalized levels of urinary N-telopeptide (71 percent versus 29 percent) and maintain those levels after 25 weeks. They also found that the denosumab arms had a lower rate of skeletal-rated events (8 percent versus 17 percent).

"This study demonstrates activity of denosumab in the setting of biologic failure of intravenous bisphosphonates," state the authors of an accompanying editorial. "Phase III trials are now awaited to define the efficacy of denosumab compared with bisphosphonates using clinical primary end points such as time to skeletal-related event in first-line therapy for patients with bone metastases."

The study was supported by Amgen, the maker of denosumab, and several of the study authors report receiving compensation from Amgen and other pharmaceutical companies.

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