OBJECTIVE： To observe clinical efficacy and safety of Xianlinggubao combined with alendronate sodium in the treatment of osteoporosis. METHODS： 112 patients with osteoporosis were randomly divided into treatment group and control group with 56 cases in each group. Both group were given routine treatment as calcium carbonate， vitamin D and life style. Control group were given alendronate sodium 10 mg orally， qd； treatment group was additionally given Xianlinggubao capsule 1.5 g， bid， on the basis of control group. Both groups received 12 weeks of treatment. The levels of S-Ca， S-P， 24 h urinary calcium （U-Ca）， alkaline phosphatase （ALP）， osteocalcin， IL-6， bone mineral density （BMD） of L2-4 lumbar spine and femoral neck were observed in 2 groups before and after treatment. ?Clinical efficacy and toxic reaction were compared. RESULTS： There was no statistical significance in the levels of S-P and S-Ca between 2 groups after treatment （P＞0.05）； the level of ALP、osteocalcin、BMD increased in treatment group after treatment， the level of U-Ca and IL-6 decreased compared to before treatment， and the treatment group was better than the control group， with statistical significance （P＜0.05）. Total effective rate of treatment group （92.86％） was significantly higher than that of control group （73.21％）， with statistical significance （P＜0.05）. No obvious toxic side effects was found in 2 groups. CONCLUSIONS： Xianlinggubao combined with alendronate sodium shows significant therapeutic efficacy for patients with osteoporosis with good safety.