Orthopedics Medical News about Denosumab, prostate cancer, bone metastases

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Denosumab treatment of prostate cancer with bone metastases and increased urine N-telopeptide levels after therapy with intravenous bisphosphonates: results of a randomized phase II trial
The Journal of Urology, 07/20/09

Fizazi K et al. - In a trial to find out whether osteoclast-mediated bone resorption can be assessed by measuring urine N-telopeptide and can be inhibited by denosumab, it was found that in pts with prostate cancer (PCa) related bone metastases and increased urine N-telopeptide despite intravenous bisphosphonate treatment, denosumab normalized urine N-telopeptide levels more frequently than ongoing intravenous bisphosphonates.

Methods

111 pts had bone metastases from PCa, other solid tumors or multiple myeloma, 1 or more bone lesions and urine N-telopeptide >50 nM bone collagen equivalents per mM creatinine (urine N-telopeptide >50) despite use of intravenous bisphosphonates.
Pts were stratified by cancer type and screening urine N-telopeptide, and randomized to continue intravenous bisphosphonates every 4 wks or receive 180 mg subcutaneous denosumab every 4 wks or 180 mg every 12 wks.
Primary endpoint was the proportion of pts with urine N-telopeptide <50 at wk 13.
Efficacy results for the subset of pts with PCa were reported.

Results

Pts with PCa represented 45% (50 of 111) of the study population.
At week 13, 22 of 32 (69%) pts in the denosumab arms had urine N-telopeptide <50 vs 3 of 16 (19%) in the intravenous bisphosphonates cohort.
At week 25, 22 of 32 (69%) denosumab-treated pts continued to have urine N-telopeptide <50 vs 5 of 16 (31%) treated with intravenous bisphosphonates.
Grade 4, asymptomatic, reversible hypophosphatemia, possibly related to denosumab, was reported in 1 pt.

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