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Drug Cuts Fracture Risk in Prostate Cancer Survivors
Reported August 13, 2009
(Ivanhoe Newswire) -- Twice-yearly treatment with denosumab, a new
targeted therapy to stop bone loss, increased bone density and prevented
spinal fractures in men receiving androgen-deprivation therapy for prostate
cancer, according to an international research study. It's the first to
document reduced fracture risk in men receiving the hormone-blocking
treatment.
"Androgen-deprivation therapy is the standard treatment for men with locally
advanced, recurrent and metastatic prostate cancer, but many active men who
have been successfully treated for their cancer develop debilitating bone
fractures as a result," Matthew Smith, MD, PhD, of the Massachusetts General
Hospital Cancer Center and associate professor of Medicine at Harvard
Medical School who led the study was quoted as saying. "The results of this
study should be critically important in improving the quality of life of
thousands of prostate cancer survivors."
About one-third of the two million prostate cancer survivors in the U.S.
currently receive androgen-deprivation therapy, which blocks the release of
testosterone. Several medications used to treat osteoporosis, including the
drugs called bisphosphonates, have been shown to reduce
androgen-deprivation-related bone loss in men in earlier small clinical
studies, but none of those trials were adequate to demonstrate reduced
fracture risk. Denosumab – a fully human monoclonal antibody that blocks the
action of osteoclasts, the cells that break down bone in the normal process
of bone remodeling – is also being investigated to prevent fractures in
women with osteoporosis.
Men undergoing androgen-deprivation therapy for non-metastatic prostate
cancer were enrolled at 156 centers in North America and Europe and randomly
assigned to receive injections of either denosumab or a placebo every six
months for three years. Participants were also instructed to take daily
calcium and vitamin D supplements during the study period.
Among the more than 900 participants who completed the study, denosumab
significantly increased bone density at all the monitored sites – including
the lumbar spine, total hip and femoral neck – and reduced new vertebral
fractures by 62 percent. Bone density at the radius, one of the bones in the
forearm, also increased in the treatment group, an improvement not seen with
other osteoporosis drugs.
Few adverse events were associated with treatment, and there were no reports
of osteonecrosis of the jaw, a problem reported in some patients taking
bisphosphonates.
"Denosumab is an important new therapy to prevent painful fractures in
prostate cancer survivors," Smith says. "An ongoing clinical trial will also
evaluate whether denosumab prevents the spread of prostate cancer to bone,
the most common site of metastases in men with this disease."
SOURCE: New England Journal of Medicine, August 20, 2009 |
