Table 3.
Turnover markers from baseline and association between 50% or greater decline and clinical benefit
| Baseline levels (median, IQR) | Maximum decline (median, IQR) | On-study maximum decline in levels of BTM of ≥50% from baseline | ||||
|---|---|---|---|---|---|---|
| PR/SD: Prop [freq/n] (90%CI) | PD/unknown*: Prop [freq/n] (90%CI) | Odds Ratio (90%CI) | Fisher Exact P-value | |||
| CTX (ng/mL) | 0.43(0.21,0.6) | −40.7 (−59.6,−32.4) | 38.9% [7/18] (20.0%,57.8%) |
40.0% [2/5] (4.0%,76.0%) |
0.95 (0.17,5.22) | p=1.000 |
| PINP (ug/mL) | 45.5(30.25,65.75) | −59.3 (−66.7,−48.4) | 83.3% [15/18] (68.9%,97.8%) |
40.0% [2/5] (4.0%,76.0%) |
7.50 (1.21,46.60) | p=0.089* |
| BALP (ug/mL) | 11(9.1,16) | −29.2 (−42.5,−11.7) | 11.8% [2/17] (0.0%,24.6%) |
20.0% [1/5] (0.0%,49.4%) |
0.53 (0.06,4.90) | p=1.000 |
| OC(ng/mL) | 16(12.25,18.75) | −50 (−61.3,−40.6) | 61.1% [11/18] (42.2%,80.0%) |
20.0% [1/5] (0.0%,49.4%) |
6.29 (0.85,46.61) | p=0.155 |
| NTX (nM BCE) | 14.9(11.3,21.3) | −32.8 (−48,−12.3) | 27.8% [5/18] (10.4%,45.1%) |
20.0% [1/5] (0.0%,49.4%) |
1.54 (0.20,11.74) | p=1.000 |
BALP, Bone-specific alkaline phosphatase; BTM, bone turnover marker, CTX, C-terminal cross-linked telopeptide of type I collagen; IQR, Interquartile range; NTX, N-terminal cross-linked telopeptide of type I collagen; OC, osteocalcin; OR, odds ratio; PD, progressive disease; PINP, N-terminal propeptide of procollagen type I; PR, partial response; prop, proportion; SD, stable disease.
*
Significance assumed at p≤0.10