OBJECTIVE： To systematically review the effectiveness of Bushen jianpi and Huoxue huayu Chinese medicine compound combined with caltrate D3 in the treatment of primary osteoporosis， and provide evidence-based reference for clinic. METHODS： Retrieved from PubMed， CJFD， Wanfang Database， VIP and CBM， randomized controlled trials （RCT） about Bushen jianpi and Huoxue huayu Chinese medicine compound combined with caltrate D3 （test group） versus caltrate D3 alone （control group） in the treatment of primary osteoporosis were collected. Meta-analysis was performed by using Rev Man 5.3 software after data extraction and quality evaluation by modified Jadad scale. RESULTS： Totally 16 RCTs were enrolled， involving 1 725 patients. Results of Meta-analysis showed， the effective rate [OR＝5.30，95％CI（3.90，7.22），P＜0.001] and bone mineral density [MD＝0.05，95％CI（0.02，0.07），P＜0.001] in test group were significantly higher than control group， visual analogue pain （VAS） score [MD＝－3.64，95％CI（－5.47，－1.82），P＜0.001] was significantly lower than control group， with statistical significance. CONCLUSIONS： Compared with caltrate D3 alone， Bushen jianpi and Huoxue huayu Chinese medicine compound combined with caltrate D3 has better efficacy in the treatment of primary osteoporosis， it can improve patients’ BMD and relief pain， with better safety.