Abstract
8000 Background: Prostate cancer recurs in 15–35% of patients even when treated early with definitive therapy. Men with rising PSA on androgen deprivation therapy (ADT) for high-risk disease have the potential to continue on LHRH agonists for years. These hypogonadal men are at risk for osteoporosis and potentially debilitating and fractures. In this study we developed a profile of men at greatest risk for bone complications. Methods: Using 1992–2001 claims data from a 5% national random sample of Medicare beneficiaries, we identified men with prostate cancer who initiated ADT in 1992–94. We analyzed all claims for bone complications over 7 subsequent years. We stratified the quartile surviving longest (>2028 days) into those who received ADT for longer or shorter than the median of 697 days. We used logistic regression modeling to formulate adjusted odds ratios for the outcomes of interest. Results: From 1992–1994, 4,494 men with prostate cancer initiated ADT. Caucasians had significantly higher risk for all fractures. Age beyond 85 years (p=0.03) and existing bone metastasis (p=0.001) significantly increased the risk of pathologic fractures. Duration of ADT (p<0.001) and presence of bone metastasis (p<0.001) were strong predictors of osteoporosis/osteopenia. Duration of ADT (p<0.001), age beyond 81 years (p=0.05), and presence of cardiovascular disease (p<0.001) each significantly increased the risk of non-pathologic fractures. ADT was associated with an increased risk of 16%, 30%, and 42% for pathologic fracture, osteoporosis/osteopenia and non-pathologic fracture, respectively. Conclusions: This study provides evidence that initiation of ADT confers a risk of bone complications greater than previously documented: in particular, increased fracture rates of 16–42%. Further, it provides physicians with a profile of who is at highest risk of bone complications. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis Pharmaceuticals Corp. Abt Associates Clinical Trials; TAP Pharmaceutical Corp. Novartis Pharmaceutical Corporation
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