Abstract: Objective: To observe the clinical effect of Yishen Qianggu Prescription for osteoporosis (OP) of kidney yang deficiency type. Methods: A total of 132 patients with OP of kidney yang deficiency type were divided into the observation group and the control group according to the random number table method, with 66 cases in each group. The control group was given oral administration of Calcium Carbonate and Vitamin D3 Tablets and Alfacalcidol Capsules, and the observation group was additionally treated with Yishen Qianggu Prescription based on the treatment of the control group. The clinical effects, incidence of adverse reactions,traditional Chinese medicine (TCM) syndrome scores,and levels of bone resorptive markers, including carboxy- terminal cross- linked telopeptide of type Ⅰcollagen (CTX- Ⅰ), β carboxy- terminal telopeptide of type I collagen (β- CTX) and tartrate- resistant acid phosphatase (TRAP), markers of bone formation, including procollagen type IN- terminal propeptide (PINP), osteocalcin (BGP) and bone-specific alkaline phosphatase (BALP),and bone density of Ward's triangle,femoral neck and L1-4 lumbar vertebrae were compared before and after treatment between the two groups. Results: Before treatment,there was no significant difference being found in the comparisons of TCM syndrome scores of soreness and weakness of the lumbar and knees,pain of the lumbar spine,wilting and weakness of lower extremities and difficult walking between the two groups (P>0.05);after treatment,the above four TCM syndrome scores in the two groups were decreased (P<0.05), and the above four scores in the observation group were lower than those in the control group (P<0.05). Before treatment,there was no significant difference being found in the comparisons of levels of CTX-Ⅰ,β-CTX and TRAP between the two groups (P>0.05);after treatment,the levels of CTX-Ⅰ,β-CTX and TRAP in the two groups were decreased (P<0.05), and the above three levels in the observation group were lower than those in the control group (P<0.05). Before treatment, there was no significant difference being found in the comparisons of levels of PINP,BGP and BALP between the two groups (P>0.05);after treatment,the levels of PINP,BGP and BALP in the two groups were increased (P<0.05),and the above three levels in the observation group were higher than those in the control group (P<0.05). Before treatment,there was no significant difference being found in the comparisons of the T values of bone density of Ward's triangle, femoral neck and L1-4 lumbar vertebrae between the two groups (P>0.05);after treatment,the T values of bone density of Ward's triangle,femoral neck and L1- 4 lumbar vertebrae in the two groups were increased (P<0.05),and the T values of bone density of above three parts in the observation group was higher than that in the control group (P<0.05). The total effective rate was 93.65% in the observation group, higher than that of 80.00% in the control group (P<0.05). During treatment, the incidence of adverse reactions was 7.94% in the observation group and 7.69% in the control group, there being no significance in the difference (P>0.05). Conclusion:Yishen Qianggu Prescription has a definite curative effect on OP of kidney yang deficiency type with good safety, and its mechanism may be related to the inhibition of bone absorption,promotion of bone formation and the increase in level of bone density.