Table 1.
Changes in biomarker levels during the study.
| Biomarker | Baseline |
Day 3 |
Month 3 |
|||||
|---|---|---|---|---|---|---|---|---|
| Placebo | Empagliflozin | Placebo | Empagliflozin | p | Placebo | Empagliflozin | p | |
| Serum calcium – mmol/L | 2.33 ± 0.10 | 2.35 ± 0.11 | 2.32 ± 0.11 | 2.35 ± 0.10 | p = 0.588 | 2.33 ± 0.09 | 2.40 ± 0.15 | p = 0.104 |
| Serum phosphate – mmol/L | 1.09 ± 0.15 | 1.10 ± 0.21 | 1.11 ± 0.19 | 1.25 ± 0.23 | p = 0.036 | 1.09 ± 0.15 | 1.17 ± 0.25 | p = 0.225 |
| 25(OH)D – ng/mL | 19.95 ± 9.07 | 15.62 ± 7.41 | 19.74 ± 9.05 | 15.77 ± 8.27 | p = 0.674 | 18.15 ± 10.25 | 17.42 ± 9.02 | p = 0.049 |
| 1,25(OH)2D – ng/L | 36.76 ± 12.39 | 35.01 ± 14.01 | 36.62 ± 14.79 | 22.09 ± 10.02 | p < 0.001 | 34.17 ± 13.95 | 31.51 ± 16.56 | p = 0.629 |
| PTH – pg/mL | 48.69 ± 25.10 | 57.40 ± 30.49 | 48.77 ± 24.99 | 70.23 ± 39.25 | p = 0.025 | 52.59 ± 16.38 | 67.82 ± 44.70 | p = 0.984 |
| FGF23 – pg/mL | 70.34 ± 14.28 | 77.92 ± 24.31 | 75.34 ± 17.60 | 109.18 ± 58.20 | p = 0.001 | 71.22 ± 13.44 | 90.29 ± 23.09 | p = 0.089 |
| β-CTX – ng/mL | 0.05 ± 0.03 | 0.07 ± 0.13 | 0.04 ± 0.03 | 0.07 ± 0.10 | p = 0.419 | 0.05 ± 0.03 | 0.05 ± 0.03 | p = 0.922 |
| Osteocalcin – ng/mL | 1.65 ± 0.03 | 1.65 ± 0.02 | 1.63 ± 0.02 | 1.64 ± 0.02 | p = 0.583 | 1.63 ± 0.02 | 1.63 ± 0.03 | p = 0.552 |
| Urine calcium/creatinine ratio | 0.29 ± 0.24 | 0.25 ± 0.13 | 0.29 ± 0.23 | 0.22 ± 0.13 | p = 0.098 | 0.25 ± 0.19 | 0.27 ± 0.16 | p = 0.684 |
| Urine phosphate/creatinine ratio | 1.88 ± 0.58 | 2.04 ± 0.54 | 2.08 ± 0.66 | 2.28 ± 0.60 | p = 0.351 | 2.13 ± 0.61 | 2.22 ± 0.49 | p = 0.640 |
Values are mean ± SD. p-values were calculated from the respective linear mixed effects models for the log-transformed value of day 3 and month 3, adjusting for the baseline value. p-values ≤ 0.05 were categorized as statistically significant.
1,25 (OH)2D = 1,25-dihydroxyvitamin D, 25(OH)D = 25-hydroxyvitamin D, β-CTX = collagen type 1 β-carboxy-telopeptide, FGF23 = fibroblast growth factor 23, PTH = parathyroid hormone.