Table 2.
Bone turnover markers, mITT population
| Time point | Marker, mean (SD) | ||||||
|---|---|---|---|---|---|---|---|
| CTX, μg/l |
CTX-I, μg/l |
CTX-II, μg/l |
CTX-II CRT, ng/mmol |
OPG, pmol/l |
PINP, μg/l |
sRANKL, pmol/l |
|
| Open-label period | |||||||
| Baselinea | 4.79 (2.09) | 0.39 (0.21) | 3.46 (2.31) | 452.4 (325.4) | 4.71 (1.80) | 52.23 (28.21) | 2057.70 (3592.90) |
| Week 12b | 4.76 (1.93) | 0.39 (0.21) | 2.99c (2.17) | 362.5d (273.1) | 4.68 (1.98) | 47.37c (26.21) | 2107.55 (3794.56) |
| Double-blind period | |||||||
| Baseline | |||||||
| RCIe | 4.77 (1.89) | 0.44 (0.22) | 3.69 (2.47) | 463.7 (316.9) | 4.86 (1.83) | 54.76 (28.79) | 1519.42 (2378.26) |
| Placebof | 4.58 (1.98) | 0.38 (0.18) | 3.61 (2.42) | 460.5 (368.3) | 4.65 (1.78) | 52.46 (26.38) | 2416.34 (3825.88) |
| Week 12 | |||||||
| RCIg | 4.58 (1.40) | 0.45 (0.23) | 2.93 (2.19) | 368.0 (228.6) | 4.79 (2.23) | 51.19 (29.06) | 2451.77h (4417.55) |
| Placeboi | 4.61 (1.63) | 0.40 (0.21) | 3.21 (2.36) | 382.5 (257.5) | 4.73 (1.89) | 48.69 (25.07) | 2358.63 (4401.72) |
| Week 24 | |||||||
| RCIj | 4.79 (2.76) | 0.44 (0.20) | 3.13 (1.87) | 339.4 (189.7) | 4.93 (2.04) | 54.34 (40.08) | 2938.96k (5006.25) |
| Placebol | 4.47 (1.68) | 0.41 (0.20) | 3.27 (2.05) | 391.6 (236.0) | 5.12 (2.12) | 53.10 (26.16) | 2105.64 (4116.93) |
Bolded values are statistically significant
CTX C-terminal crosslinking telopeptide, CTX-I C-terminal crosslinking telopeptide of type I collagen, CTX-II C-terminal crosslinking telopeptide of type II collagen, CTX-II CRT creatinine-adjusted CTX-II, mITT modified intent-to-treat, OPG osteoprotegerin, PINP N-terminal peptide of type I collagen, RCI repository corticotropin injection, SD standard deviation, sRANKL soluble receptor activator of nuclear kappa B ligand
aCTX, n = 251; CTX-I and OPG, n = 254; CTX-II, n = 190; CTX-II CRT, n = 183; PINP, n = 257; sRANKL, n = 250
bCTX, n = 238; CTX-I, n = 243; CTX-II, n = 159; CTX-II CRT, n = 153; OPG, n = 239; PINP, n = 246; sRANKL, n = 231
cp < 0.01, one-sample t test for week 12 versus baseline
dp < 0.001, one-sample t test for week 12 versus baseline
eCTX, CTX-I, and PINP, n = 75; CTX-II, n = 59; CTX-II CRT, n = 57; OPG and sRANKL, n = 73
fCTX, n = 72; CTX-I, OPG, and sRANKL, n = 75; CTX-II, n = 59; CTX-II CRT, n = 57; PINP, n = 76
gCTX, CTX-I, and PINP, n = 75; CTX-II, n = 66; CTX-II CRT, n = 64; OPG, n = 74; sRANKL, n = 72
hp < 0.05, two-sample t test for RCI time point versus baseline
iCTX, n = 73; CTX-I, OPG, and PINP, n = 74; CTX-II, n = 62; CTX-II CRT, n = 61; sRANKL, n = 71
jCTX, CTX-I, and PINP, n = 75; CTX-II and CTX-II CRT, n = 63; OPG, n = 74; sRANKL, n = 70
kp < 0.01, two-sample t test for RCI time point versus baseline
lCTX, CTX-I, OPG, and PINP, n = 65; CTX-II, n = 46; CTX-II CRT, n = 45; sRANKL, n = 61