Table 2.
Factors Associated With the Risk of Multiple Vertebral Fractures (MVFs) After Denosumab Discontinuation
| No MVF in period 3 mean (SD) or n (%) | MVF in period 3 (yes) mean (SD) or n (%) | Univariate analysis | Multivariate analysis | |||
|---|---|---|---|---|---|---|
| OR | p Value | OR | p Value | |||
| Total | 715 (92.62%) | 57 (7.38%) | ||||
| At denosumab initiation (period 1) | ||||||
| Age (years) | 65.27 (9.13) | 64.71 (10.25) | 0.99 | 0.66 | ||
| Body mass index (kg/m2) | 23.08 (3.96) | 23.18 (4.33) | 1.005 | 0.90 | ||
| Weight (kg) | 60.01 (10.59) | 62.16 (11.07) | 1.02 | 0.26 | ||
| Breast cancer | 117 (16.36%) | 13 (22.81%) | 1.51 | 0.21 | ||
| Parental hip fracture | 83 (11.61%) | 13 (22.81%) | 2.25 | 0.02 | ||
| T‐score lumbar spine | −2.53 (0.99) | −2.68 (0.90) | 0.85 | 0.36 | ||
| T‐score total hip | −1.74 (0.76) | −1.91 (0.81) | 0.74 | 0.21 | ||
| T‐score femoral neck | −2.05 (0.75) | −2.12 (0.94) | 0.87 | 0.56 | ||
| Bone resorption markers a | 0.76 (0.45) | 1.07 (0.64) | 3.16 | 0.03 | ||
| Previous vertebral fracture | 131 (18.32%) | 17 (29.82%) | 1.89 | 0.04 | 5.34 | 0.006 |
| Previous non‐vertebral fracture | 141 (19.72%) | 11 (19.30%) | 0.97 | 0.94 | ||
| Previous bisphosphonates | 355 (59.66%) b | 12 (24.49%) c | 0.22 | <0.0001 | 0.10 | <0.0001 |
| During denosumab treatment (period 2) | ||||||
| No. of denosumab doses | 5.92 (3.16) | 5.69 (3.11) | 0.98 | 0.61 | ||
| Duration of denosumab treatment (months) | 35.02 (18.94) | 34.70 (19.76) | 0.99 | 0.90 | ||
| Vertebral fractures | 17 (2.38) | 1 (1.75) | 0.73 | 0.77 | ||
| Non‐vertebral fractures | 22 (3.08) | 2 (3.51) | 1.14 | 0.86 | ||
| T‐score lumbar spine | −1.88 (1.13) | −2.0 (0.86) | 0.89 | 0.48 | ||
| T‐score change period 2–1 | 0.70 (0.62) | 0.70 (0.36) | 1.004 | 0.99 | ||
| T‐score total hip | −1.42 (0.84) | −1.86 (0.73) | 0.50 | 0.002 | 0.38 | 0.002 |
| T‐score change period 2–1 | 0.29 (0.37) | 0.18 (0.37) | 0.37 | 0.14 | ||
| T‐score femoral neck | −1.80 (0.78) | −1.96 (0.78) | 0.76 | 0.28 | ||
| T‐score change period 2–1 | 0.22 (0.44) | 0.20 (0.38) | 0.87 | 0.81 | ||
| After denosumab treatment (period 3) | ||||||
| T‐score lumbar spine | −2.12 (1.17) | −2.48 (1.06) | 0.74 | 0.05 | ||
| T‐score change period 3–2 | −0.25 (0.64) | −0.43 (0.76) | 0.69 | 0.14 | ||
| T‐score change period 3–1 | 0.41 (0.62) | 0.20 (0.73) | 0.58 | 0.05 | ||
| T‐score total hip | −1.63 (0.80) | −1.94 (0.86) | 0.62 | 0.01 | ||
| T‐score change period 3–2 | −0.18 (0.43) | −0.08 (0.38) | 2.18 | 0.14 | ||
| T‐score change period 3–1 | 0.12 (0.35) | 0.04 (0.43) | 0.54 | 0.25 | ||
| T‐score femoral neck | −1.91 (0.75) | −2.19 (0.75) | 0.58 | 0.01 | ||
| T‐score change period 3–2 | −0.10 (0.42) | −0.18 (0.35) | 0.62 | 0.33 | ||
| T‐score change period 3–1 | 0.10 (0.40) | −0.03 (0.43) | 0.49 | 0.08 | ||
| Bone resorption markers a | 0.66 (0.64) | 1.28 (1.13) | 2.31 | <0.0001 | ||
| Non‐vertebral fractures | 11 (1.54%) | 5 (8.77%) | 6.15 | 0.001 | ||
| Bisphosphonate after denosumab | 487 (68.11%) | 7 (12.28%) | 0.07 | <0.0001 | 0.006 | <0.0001 |
OR = odds ratio.
Logistic regression model analysis.
a
Bone resorption markers are indicated in % of the upper premenopausal normal limit of the given method.
b
Refers to total 595 (data missing for 120 patients).
c
Refers to total 49 (data missing for 8 patients).