Abstract: Objective To investigate the efficacy and safety of gemcitabine combined with zoledronic acid in treatment of breast cancer patients with multiple bone metastases. Methods The randomized,controlled method was adopted.Fifty-two breast cancer patients with multiple bone metastases were randomly assigned to trial group (28 cases)and control group (24 cases),the trial group was administered with gemcitabine plus zoledronic acid and the control group was administered with gemcitabine alone.The effect in the two groups was compared. Results The over all response and the clinical benefit rate(CR+PR+SD≥6 months)of the trial group was 50.0% and 67.9%,and the control group was 45.8% and 54.2%,respectively.The curative effeiciency,improvement in quality of life,and toxic side effects between the two groups had no significant difference.Relief of bone pain was 78.5% in trial group,which was significantly higher than that in control group (45.8%),there was statistic difference（χ²=5.97，P<0.05). Conclusion Gemcitabine combined with Zoledronic acid for breast cancer patients with bone metastases has synergistic effect and favorable therapeutic efficacy and relief of bone pain and improving quality of life.The adverse effects is well-tolerated.