Two-year effectiveness of zoledronic acid with or without eldecalcitol in Japanese patients with osteoporosis: A randomized prospective study

OBJECTIVES: This study aims to examine the 2-year outcomes of zoledronic acid (ZOL) with or without eldecalcitol (ELD) on bone mineral density (BMD) and fracture in Japanese patients with osteoporosis. METHODS: The subjects were 98 patients who were randomly (1:1) assigned to treatment with ZOL combined with ELD (ZOL + ELD group; n = 51) and ZOL alone (ZOL group; n = 47). Treatment efficacy was examined based on a comparison of changes in BMD from baseline (ΔBMD) in the lumbar spine, total hip, and femoral neck in the 2 groups. RESULTS: The percent change from baseline in BMD values for the lumbar spine, total hip, and femoral neck at 24 months were 10.8% ± 6.1%, 6.0% ± 6.6%, and 5.1% ± 5.1%, respectively, in the ZOL + ELD group, and 7.7% ± 6.2%, 5.1% ± 5.6%, and 2.9% ± 8.3%, respectively, in the ZOL group. The percent change from baseline BMD for the lumbar spine at 24 months differed significantly between the 2 groups. CONCLUSIONS: The effect of a combination of ZOL + ELD on BMD for 24 months was more favorable than that of ZOL alone. This drug combination is promising for the treatment of drug-naïve Japanese patients with primary osteoporosis.