Abstract： Objective： To observe the clinical effect and safety of Bushen Yigan Huoxue Decoction combined with Alfacalcidol Capsules for senile patients with primary osteoporosis (OP). Methods：A total of 116 cases of senile patients with primary OP were selected and divided into the control group and the treatment group according to the random number table method，with 58 cases in each group. The control group was treated with Alfacalcidol Capsules， and the treatment group was treated with Bushen Yigan Huoxue Decoction combined with Alfacalcidol Capsules. The clinical effects and the incidence of adverse reactions in the two groups were observed；the changes of traditional Chinese medicine (TCM) syndrome scores，bone metabolism indexes [bone alkaline phosphatase (BALP)，bone gla protein (BGP)，procollagen ⅠN-terminal propeptide (PⅠNP)] and bone mineral density levels were compared before and after treatment between the two groups. Results：The total effective rate was 98.28% in the treatment group and 86.21% in the control group， the difference being significant (P＜0.05). After treatment， the scores of soreness and pain in waist and knee，stabbing pain in the lumbar spine，fever of palms and sole，and wilting and weakness of lower extremities in the two groups were decreased when compared with those before treatment (P＜0.05)， and the above four TCM syndrome scores in the treatment group were lower than those in the control group (P＜0.05). After treatment，the bone mineral density of lumbar L2- 4 and femoral neck in the two groups was increased when compared with that before treatment (P＜0.05)，and the bone mineral density of lumbar L2- 4 and femoral neck in the treatment group was higher than that in the control group (P＜0.05). After treatment，BGP levels in the two groups were increased when compared with those before treatment (P＜0.05)，and the levels of BALP and PⅠNP were decreased when compared with those before treatment (P＜0.05)；the BGP level in the treatment group was higher than that in the control group (P＜0.05)，and the levels of BALP and P ⅠNP were lower than those in the control group (P＜0.05). The incidence of adverse reactions was 17.24% in the control group and 3.45% in the treatment group， the difference being significant (P＜0.05). Conclusion： Bushen Yigan Huoxue Decoction combined with Alfacalcidol Capsules has a significant curative effect in treating senile patients with primary OP，which can alleviate clinical symptoms，improve bone metabolism，increase bone mineral density and reduce adverse reactions.