Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer.

Purpose: The development of bone metastases depends on tumor-induced osteoclastic resorption of bone, which may be inhibited by the antiosteolytic bisphosphonate clodronate. Given to patients with primary breast cancer, clodronate might reduce the subsequent incidence of bone metastases.

Patients And Methods: This double-blind, multicenter trial accrued 1,069 assessable patients with operable breast cancer between 1989 and 1995.