Clinical investigation of effects of eldecalcitol on lipid profile and other metabolic parameters in osteoporosis-treatment-naïve postmenopausal women with osteoporosis.

Osteoporosis is characterized by decreased bone mass and disruption of bone architecture. Eldecalcitol is the newest analog of activated vitamin D that can improve osteoporosis. In addition, dietary/activated vitamin D can improve metabolic parameters. Clinical studies have shown that activated vitamin D analogs improve glucose tolerance and hepatic function. However, the effects of activated vitamin D analogs, including eldecalcitol, on lipid parameters are yet to be clinically investigated. We aimed to reveal the effects of eldecalcitol on lipids and other metabolic parameters for 24 weeks in 54 osteoporosis-treatment-naïve postmenopausal women with osteoporosis. We measured metabolic parameters before and 24 weeks after administration of eldecalcitol (0.75 μg per day) without changing the patients' other medications. All patients completed the study without complications, and T-scores (lumbar spine and femoral neck) significantly improved from baseline to 24 weeks after eldecalcitol administration (each P < 0.001). Regarding metabolic parameters, low-density lipoprotein-cholesterol levels decreased significantly (P = 0.007), and levels of glycated hemoglobin, alanine aminotransferase, and γ-glutamyl transferase decreased significantly (each P < 0.05). Holm method for sensitivity analysis of the metabolic parameters revealed that there were no significant changes, but there was a trend of improvement in LDL-C (P = 0.056). Univariate regression analysis showed that age, body mass index, and changes in all metabolic parameters were not associated with T-score improvement. These results indicated that eldecalcitol might affect lipid metabolism and other metabolic parameters. Larger, controlled prospective studies with prespecified endpoints are required to determine whether eldecalcitol affects lipid and other metabolic parameters.