Effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer.

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J Urol. 2009 Dec;182(6):2670-5.
Effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer.
Smith MR, Saad F, Egerdie B, Szwedowski M, Tammela TL, Ke C, Leder BZ, Goessl C.
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, USA.

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PURPOSE:
In a recently completed 3-year, randomized, double-blind study,
denosumab, a fully human monoclonal antibody against receptor activator
of nuclear factor kappaB ligand, significantly increased bone mineral
density and decreased new vertebral fractures in men receiving androgen
deprivation therapy for prostate cancer. We conducted subgroup analyses
to evaluate the relationships between subject characteristics and the
effects of denosumab on bone mineral density at multiple skeletal
sites.
MATERIALS AND METHODS: A total of 1,468 subjects were randomized
1:1 to receive 60 mg subcutaneous denosumab every 6 months or placebo
for 36 months. In these analyses we evaluated the effects of denosumab
on bone mineral density at the lumbar spine, total hip and distal 1/3
radius (substudy of 309 subjects) during 36 months in 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.
RESULTS: After 36 months 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. CONCLUSIONS: Denosumab
significantly and consistently increased bone mineral density at all
skeletal sites and in every subgroup, including men at greatest risk
for bone loss and fractures.