The relatively new drug, denosumab, has proven itself very effective for men on a hormone blockade (ADT). In a recently completed 3-year, randomized, double-blind study at the Massachusetts General Hospital Cancer Center, Boston, Massachusetts, denosumab significantly increased bone mineral density and decreased new vertebral fractures in men receiving ADT for the treatment of advanced prostate cancer.
The trial, which had 1,468 subjects, was randomized 1:1 with the trial group to receive 60 mg subcutaneous denosumab every 6 months against a placebo group. The trial ran for 36 months. The researchers then analyzed the effects of denosumab on bone mineral density at the lumbar spine, total hip and distal 1/3 radius (substudy of 309 subjects). They took into account specific subgroups according to age, duration and type of prior androgen deprivation therapy, bone mineral density T score, weight, body mass index, bone turnover marker levels and prevalent vertebral fractures.
The men, who after 36 months of receiving denosumab, significantly increased bone mineral density of the lumbar spine, total hip and distal 1/3 radius by 7.9%, 5.7% and 6.9%, respectively, compared with placebo (p <0.0001 for each comparison). Denosumab significantly increased bone mineral density to a degree similar to that observed in the overall analysis for every subgroup including older men as well as those with prevalent fractures, lower baseline bone mineral density, and higher serum C-telopeptide and tartrate-resistant alkaline phosphatase 5b. Mean increases in bone mineral density at each skeletal site were greatest for men with the highest levels of serum C-telopeptide and tartrate-resistant alkaline phosphatase 5b.This trial clearly confirm the prior research that denosumab significantly and consistently increased bone mineral density at all skeletal sites and in every subgroup, including those of us at greatest risk for bone loss and fractures. Reference: J Urol. 2009 Oct 15. (Epub ahead of print); Smith MR, Saad F, Egerdie B, Szwedowski M, Tammela TL, Ke C, Leder BZ, Goessl C 10.1016/j.juro.2009.08.048PubMed Abstract PMID: 19836774Joel T Nowak MA, MSW