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Sodium clodronate is an oral, first-generation bisphosphonate that is not commercially available in the U.S. In the mid-1990s, U.K. investigators initiated two randomized, double-blind, placebo-controlled trials to assess whether this agent — when added to conventional androgen-deprivation therapy (ADT) — could modulate bone metastasis in men with prostate cancer. In both studies, the primary endpoint was time to symptomatic bone-progression–free survival (BPFS), and the secondary endpoint was overall survival (OS).
In the first study, involving men with metastatic disease (J Natl Cancer Inst 2003; 95:1300), 311 patients with bone metastases who were initiating or responding to ADT were randomized to receive either clodronate (2080 mg daily)…