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

Matthew R. Smith, F Saad, Blair Egerdie, Paul Sieber, Teuvo L J Tammela, Benjamin Z. Leder, Chunlei Ke, Carsten Goessl

Research output: Contribution to journalArticleScientificpeer-review

22 Citations (Scopus)

Abstract

<p>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), and baseline BTM (a:circ median versus > median BTM values). Treatment with denosumab provided a rapid and sustained decrease of BTM values compared with placebo. The median change in sCTX levels at month 1 was -90% in the denosumab group and -3% in the placebo group (p <0.0001). The median change in TRAP-5b levels at month 1 was -55% in the denosumab group and -3% in the placebo group (p <0.0001). The maximal median change in P1NP was -64% in the denosumab group and -11% in the placebo group, (p <0.0001). Significantly greater decreases in BTM for denosumab were also seen in subgroup analyses based on age, prior ADT treatment, and baseline BTM values. Suppression of bone turnover markers was consistent with marked increases in bone mineral density reported previously. © 2011 American Society for Bone and Mineral Research</p>
Original languageEnglish
Pages (from-to)2827-2833
Number of pages7
JournalJournal of Bone and Mineral Research
Volume26
Issue number12
DOIs
Publication statusPublished - 2011
Publication typeA1 Journal article-refereed

Keywords

  • ANDROGEN DEPRIVATION THERAPY
  • BONE TURNOVER MARKERS
  • DENOSUMAB
  • PROSTATE CANCER

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