Long-term socioeconomic impacts of Aredia on the evolution of bone metastases (BM) were evaluated retrospectively in a multicenter, controlled, randomized phase III trial in patients with advanced breast cancer and BM receiving first-line chemotherapy. Randomization was between chemotherapy alone vs. chemotherapy plus Aredia (45 mg, intravenously, during 1 hr, every 3 weeks until bone progression).Analysis of the socioeconomic impacts of Aredia concentrated on the quality of life with respect to the treatment itself, the observed complications of BM, the time to progressive disease in bone, the time to first radiotherapy, and the WHO performance status.Measures of quality of life were evaluated, using the so-called Rosser scale, relating degrees of disability to distress ratings, in terms of quality-adjusted life-years (QALYs). The gain in QALYs before progressive disease in bone, plus the days to first complications, plus the gain in days to first radiotherapy, amounted to a total of 21.4 QALYs per 100 patients. - Analysis of economic impacts was restricted to a few cost elements because the clinical trial did not include any economic endpoints.The data collected during this phase III clinical trial contained a great wealth of useful information. Unfortunately, the data on input of resources were incomplete. In the future, information on patient management that also may be collected during clinical trials (referals to hospital, doctor visits, etc.) will play an increasingly more important role as a basis for socioeconomic studies.