Denosumab and changes in bone turnover markers during androgen deprivation therapy for prostate cancer.

ABSTRACT: Androgen deprivation therapy (ADT) for prostate cancer increases fracture risk, decreases bone mineral density, and increases bone turnover markers (BTMs) including serum type 1 C-telopeptide (sCTX), tartrate-resistant alkaline phosphatase 5b (TRAP-5b), and procollagen-1 N-terminal telopeptide (P1NP). In a prespecified exploratory analysis of a phase 3, multicenter, double-blind study, we evaluated the effects of denosumab (60 mg subcutaneously every 6 months for 3 years) versus placebo (1468 patients, 734 in each group) on BTM values. BTMs were measured at baseline, month 1, and predose at months 6, 12, 24, and 36 in the overall population. BTMs at month 1 are also reported for subgroups based on age (<  70 years versus ≥  70 years), prior duration of ADT (≤  6 months versus > 6 months),

SUBMITTER: Smith MR 

PROVIDER: S-EPMC3222788 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature