Table 2.
Changes from baseline in bone biomarker values to first (4 weeks) and last postbaseline values.
| Baseline |
First postbaseline value (4 weeks) |
Change from baseline to first postbaseline value (4 weeks) |
Last postbaseline value (24 weeks or earlier) |
Change from baseline to last postbaseline value |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Mean (SD) | Median (range) | n | Mean (SD) | Median (range) | n | Mean (SD) | Median (range) | P-valuea | n | Mean (SD) | Median (range) | n | Mean (SD) | Median (range) | P-valuea | |
| CTX (ng/ml) | 230 | 0.15 (0.34) | 0.08 (0.01‒4.95) |
211 | 0.14 (0.33) | 0.08 (0.01‒4.44) |
195 | −0.01 (0.12) | 0.00 (−0.51‒0.96) |
0.322 | 214 | 0.13 (0.12) | 0.10 (0.01‒0.72) |
196 | −0.01 (0.36) | 0.01 (−4.76‒0.50) |
0.036 |
| Osteocalcin (ng/ml) | 241 | 10.71 (9.04) | 8.20 (0.97‒77.18) | 221 | 11.24 (12.15) | 8.04 (0.69‒134.90) | 210 | 0.12 (8.40) | −0.29 (−42.94‒82.88) | 0.395 | 219 | 9.85 (8.21) | 7.81 (1.00‒77.90) | 208 | −1.45 (7.05) | −0.96 (−40.88‒25.88) | < 0.001 |
| P1NP (ng/ml) | 241 | 84.09 (91.63) | 53.70 (10.82‒619.40) | 221 | 60.56 (62.54) | 39.62 (6.68‒323.30) | 210 | −22.16 (62.18) | −10.44 (−594.15‒108.93) | < 0.001 | 218 | 66.83 (122.59) | 37.06 (6.20‒1603.00) | 207 | −24.29 (78.68) | −11.53 (−589.95‒381.71) | < 0.001 |
| PTH (pg/ml) | 239 | 42.99 (204.36) | 20.59 (1.35‒3158.00) | 220 | 45.20 (143.25) | 23.73 (2.37‒2072.00) | 208 | 1.55 (82.67) | 2.38 (−1086.00‒206.34) | 0.008 | 220 | 40.84 (47.08) | 28.70 (1.36‒447.50) | 208 | −3.18 (220.51) | 6.30 (−3103.47‒381.74) | < 0.001 |
| 25-OH-vitamin D (ng/ml) | 239 | 24.62 (13.76) | 21.36 (3.92‒65.03) | 221 | 22.91 (13.16) | 20.81 (3.26‒66.83) | 209 | −1.29 (3.83) | −1.28 (−12.71‒9.93) | < 0.001 | 218 | 22.29 (14.16) | 18.62 (3.40‒69.64) | 207 | −1.96 (5.81) | −1.89 (−28.99‒21.78) | < 0.001 |
Abbreviations: 25-OH-vitamin D, 25-hydroxyvitamin D; CTX, C-terminal cross-linking telopeptide of type 1 collagen; P1NP, procollagen type 1 N-terminal peptide; PTH, parathyroid hormone; SD, standard deviation.
a
P-values for change from baseline used the Wilcoxon signed-rank test for differences in biomarker concentrations. Statistical significance was accepted when P < 0.05 (bold text).