Superior Efficacy of Denosumab Over Zoledronic Acid in Increasing Femoral Neck Bone Mineral Density in Osteoporosis Patients With Type 2 Diabetes Mellitus.

OBJECTIVES

This study aimed to compare the antiosteoporotic efficacy of zoledronic acid (ZOL) with denosumab (DEN) in osteoporosis patients with type 2 diabetes mellitus (T2DM).

METHODS

This was a prospective, open-label, nonrandomized clinical study. Osteoporotic women with T2DM aged 50 to 80 years were enrolled and assigned to either the ZOL group (n = 45) or the DEN group (n = 75) based on patient preference. The efficacy endpoint included the percent change from baseline in bone mineral density (BMD), bone turnover markers, and the fracture risk evaluated by the fracture risk assessment tool after 1 year. The propensity score-matched analysis was performed to confirm the robustness.

RESULTS

After 1-year of treatment, DEN was more effective than ZOL at increasing femoral neck BMD (least-squares mean [LS mean] difference 4.59% [95% confidence interval [CI]: 0.93% to 8.25%]; P = .017), but not at BMD in the lumbar spine or total hip. Besides, compared with the ZOL group, the DEN group demonstrated greater suppression of osteocalcin (LS mean difference -20.58% [95% CI: -39.93 to -1.24]; P = .041) and a greater reduction in major osteoporotic fracture risk (LS mean difference -11.20% [95% CI: -20.76 to -1.64]; P = .025).

CONCLUSIONS

The results suggest that DEN should be considered as a potentially better option for T2DM patients who have low femoral neck BMD.