Pamidronate treatment in patients with malignant osteolytic bone disease and pain - A prospective randomized double-blind trial

The aim of this double-blind, randomized study was to compare the effects o f two pamidronate dosages, given as repeated infusions in patients with adv anced malignant osteolytic bone disease and bone pain. Seventy patients wer e randomly assigned to receive pamidronate 60 mg or 90 mg i.v. every 3 week s for a maximum of six cycles. Pain parameters, analgesic consumption and p erformance status were assessed at baseline and throughout the study. Furth ermore, total-body bone mineral density was measured using dual-energy X-ra y absorptiometry at baseline, after three and after six infusions. Sixty pe rcent (95% CI 41-77%) of the patients in the 60 mg group and 63% (95% CI 44 -79%) of the patients in the 90-mg group had a sustained reduction of pain intensity and were classified as pain responders. Median duration of pain r esponse was 15 versus 12 weeks in the 60-mg and 90-mg groups, respectively (P=0.32). After two infusions, significant changes in pain intensity, pain frequency, general well-being and WHO pain score were observed (P<0.01). A trend toward improved performance status and reduced consumption of analges ics was also observed. Patients in the 90-mg group had more pronounced bone remineralization as measured by total-body bone mineral density. No signif icant difference was detectable between the two pamidronate treatments in a ny of the parameters evaluated. In conclusion, bone pain can be effectively reduced by repeated pamidronate infusions in patients with advanced osteol ytic bone disease. Pamidronate 90 mg every 3 weeks results in higher bone r emineralization, but this difference did not translate into a further incre ase of palliative effects.