Abstract: Objective: To observe the clinical effect of Dumo Yishen Huazhuo Tongluo prescription for primary osteoporosis. Methods:A total of 94 cases of patients with primary osteoporosis were divided into the study group and the control group according to the random number table method,with 47 cases in each group. All patients were given routine treatment including activated vitamin D3 and calcium agent; the control group was additionally treated with alendronate sodium,and the study group was additionally treated with Dumo Yishen Huazhuo Tongluo prescription. After two months of treatment, the clinical effects and adverse reations in the two groups were compared; the levels of bone mineral density (bone neck,lumbar vertebra,greater trochanter),the bone metabolism indexes including alkaline phosphatase(ALP),Ntelopeptide of type I collagen(NTX) and bone gla protein(BGP) as well as the Chinese medicine syndrome scores before and after treatment in the two groups were compared. Results: The total effective rate was 91.49% in the study group and 74.47% in the control group,the difference being significant(P<0.05). Before treatment,there was no significant difference being found in the comparison of the levels of bone mineral density in femur neck,lumbar vertebra and greater trochanter between the two groups(P>0.05). After treatment,the above levels of bone mineral density in the study group were higher than those in the control group(P<0.05). Before treatment,there was no significant difference being found in the comparison of the levels of bone metabolism indexes including ALP,NTX and BGP between the two groups(P>0.05). After treatment, the levels of ALP and NTX in the study group were lower than those in the control group,and BGP level was higher(P<0.05). Before treatment,there was no significant difference being found in the comparison of the scores of the clinical symptoms including lumbar and back pain,soreness and weakness of waist and knees,mental and physical lassitude,insomnia and dreaminess, dizziness and tinnitus between the two groups(P>0.05). After treatment, the above scores of Chinese medicine syndromes in the study group were lower than those in the control group(P<0.05). The incidence of adverse reactions was 2.13% in the study group and 14.89% in the control group, the difference being significant(P<0.05). Conclusion:The application of Dumo Yishen Huazhuo Tongluo prescription for primary osteoporosis can effectively improve the levels of bone mineral density and promote the improvement of bone metabolism, with low incidence of adverse reactions.