Table 3 Univariate Cox regression analysis of bone markers in bladder cancer after 18 months of ZOL treatment

Variable	HR	95% CI (HR)	P-value
Death
Abnormal baseline β-CTX levels (>0.548 ng ml⁻¹)	2.062	0.732–5.813	0.171
High baseline β-CTX levels (>0.9 ng ml⁻¹, ROC cutoff)	3.672	1.353–9.967	0.010^a
No normalisation of β-CTX levels in v₁^b	—	—	—
Abnormal baseline BALP levels (>15 UI l⁻¹)	0.963	0.321–2.888	0.946
High baseline BALP levels (>45.9 UI l⁻¹, ROC cutoff)	2.597	1.08–6.248	0.033^a
No normalisation of BALP levels in v₁^b	—	—	—
Abnormal baseline PINP levels (>62 ng ml⁻¹)	1.096	0.367–3.273	0.869
High baseline PINP levels (>128.7 ng ml⁻¹, ROC cutoff)	1.313	0.54–3.191	0.548
No normalisation of PINP levels in v₁	0.963	0.225–4.13	0.96
Disease progression
This analysis was not made because Kaplan–Meier curves showed no statistically significance and it did not comply with assumption of proportional risk	—	—	—
Skeletal-related events
Abnormal baseline β-CTX levels (>0.548 ng ml⁻¹)	1.427	0.387–5.268	0.593
High baseline β-CTX levels (>0.8 ng ml⁻¹, ROC cutoff)	2.714	0.811–9.085	0.105
No normalisation of β-CTX levels in v₁^b	—	—	—
Abnormal baseline BALP levels (>15 UI l⁻¹)	0.408	0.076–2.178	0.294
High baseline BALP levels (>19.9 UI l⁻¹, ROC cutoff)	2.819	0.727–10.92	0.134
No normalisation of BALP levels in v₁	—	—	—
Abnormal baseline PINP levels (>62 ng ml⁻¹)	1.764	0.389–7.993	0.461
High baseline PINP levels (>106.8 ng ml⁻¹, ROC cutoff)	2.418	0.797–7.33	0.119
No normalisation of PINP levels in v₁	1.136	0.267–4.837	0.863

Abbreviations: BALP=bone alkaline phosphatase; β-CTX=beta-isomer of carboxy-terminal telopeptide of type I collagen; CI=confidence interval; HR=hazard ratio; PINP=procollagen type I amino-terminal propeptide; ROC=receiver operating characteristic; v₁=visit 1; ZOL=zoledronic acid.
Relative changes between v₁ and v₀ did not show statistically significant results and they are not shown.
Statistically significant results.
There were no patients with abnormal levels in v₁.

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