Differential assessment of fracture frequency and risk in patients undergoing hemodialysis depending on the treatment of mineral and bone disorders: Prospective cohort study with historical control

Abstract

The present study aimed to assess the incidence, risk, and timing of fractures in patients undergoing hemodialysis with secondary hyperparathyroidism (SHPT), following the correction of mineral and bone disorders (MBD).
 Methods. This prospective cohort open-label study involving 242 patients was conducted between 2019 and 2022. The patients were categorized into three groups based on MBD treatment. Group 1 (n=64) represented a historical cohort without modern treatment, while Group 2 (n=153) received contemporary MBD and SHPT correction. Group 3 (n=22) included patients prescribed selective vitamin D receptor activators in addition to modern therapy.Patients underwent regular assessments, including calcium, phosphorus, and parathyroid hormone measurements every three months, therapy adjustments, fracture diagnosis, and treatment over a 24-month follow-up period.
 Results. Our findings revealed a significantly higher cumulative proportion of patients without bone fractures in Group 2 compared to the historical control, with survival rates of 75.8% and 92.6%, respectively (p=0.0006). The average life expectancy before fractures in Group 2 was 695.77±10.19 days, significantly longer than the historical group (p < 0.0001), and the risk of bone fractures decreased by more than four times (HR 0.2274, 95% CI: 0.0965 – 0.5358).
 Comparing Groups 1 and 3 showed even more positive outcomes. The cumulative proportion of patients without fractures at the end of the study was 75.8% in Group 1 and 95.5% in Group 3 (p = 0.0441), with a life expectancy before fractures of 630.88±24.29 days and 724.38±5.48 days, respectively (p < 0.0001). The risk for bone fractures decreased by one-third in Group 3 (HR 0.3390, 95% CI: 0.0838 - 0.9058). The average life expectancy before fractures in Group 3 was significantly longer than in Group 2 (p < 0.0001), although the cumulative proportion of patients without fractures did not differ significantly (95.5% vs. 92.6%, p > 0.05).
 Conclusions. The study demonstrates that correcting SHPT and MBD with non-calcium phosphate binders, calcimimetics, and paricalcitol or vitamin D reduces fracture incidence and risk, and increases the treatment duration until a fracture episode occurs in patients undergoing hemodialysis.