A Phase III Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Odanacatib) in Prolonging Bone Metastasis-Free Survival in Men with Castration-Resistant Prostate Cancer

Update Il y a 5 ans
Reference: EUCTR2008-002120-29

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Extract

• To assess the effect of treatment with MK-0822 5 mg once daily on bone metastasis-free survival (defined as time to first bone metastasis or death from any cause) compared to placebo. • To assess the effect of treatment with MK-0822 5 mg once daily in a subset of 300 patients on lumbar spine, total hip, femoral neck, trochanter and total body bone mineral density (BMD) compared to placebo. • To assess the tolerability of treatment with MK-0822 5 mg once daily compared to placebo.


Inclusion criteria

  • Prevention of bone metastases in men with prostate cancer

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