The aim of our study was to evaluate the efficacy of oral clodronate supple
menting systemic therapy and/or palliative irradiation in 91 patients with
painful bone metastases. Clodronate was administered at a daily dose of 160
0-3200 mg for a median of 11 months (range 3-36 months). Partial or complet
e pain relief was achieved in 61 of 88 evaluable patients (69%). Response r
ate to clodronate in patients who additionally received palliative bone rad
iation was similar to that in patients who did not receive irradiation (68
and 71%, respectively). Eleven out of 12 bed-ridden patients with metastati
c bone pain regained the ability of walking after the treatment with clodro
nate. Bone pain relief lasted from 1.5 to 36 months (mean 9.3 months). Clod
ronate was well tolerated in all but three cases (3%) in whom the treatment
was discontinued due to intensive adverse gastrointestinal effects. in con
clusion, we observed satisfactory symptomatic effect and low rate of advers
e reactions in patients with metastatic bone lesions treated with oral clod
ronate. Further large controlled studies with thorough patient monitoring a
re warranted to evaluate the real benefit of clodronate, and to define its
optimal scheduling.