Table 3.
Baseline |
Final (after 16 weeks) |
Difference in change (95% CI)d |
||||||
---|---|---|---|---|---|---|---|---|
Placebo | 10 μg | 25 μg | Placebo | 10 μg | 25 μg | 10 μg | 25 μg | |
Serum 25(OHD) (nmol/L) | 29.2 (15.6) | 30.7 (20.1) | 26.8 (17.1) | 27.5 (13.7) | 45.9 (18.7) | 51.1 (20.1) | 16.7 (11.2, 22.3)‡ | 26.1 (20.4, 31.9)‡ |
Serum calcium (mmol/L) | 2.36 (0.1) | 2.37 (0.08) | 2.37 (0.09) | 2.36 (0.11) | 2.35 (0.13) | 2.38 (0.10) | − 0.02 (− 0.06, 0.01) | 0.003 (− 0.02, 0.03) |
Serum corrected calcium (mmol/L)b | 2.30 (0.08) | 2.31 (0.06) | 2.32 (0.08) | 2.34 (0.10) | 2.32 (0.11) | 2.33 (0.10) | − 0.02 (− 0.05, 0.01) | − 0.003 (− 0.02, 0.02) |
Serum phosphate (mmol/L) | 1.15 (0.15) | 1.16 (0.16) | 1.13 (0.13) | 1.14 (0.18) | 1.15 (0.16) | 1.15 (0.16) | − 0.002 (− 0.05, 0.05) | 0.04 (− 0.01, 0.08) |
Plasma PTH (pmol/L)c | 8.1 (4.0) | 7.1 (3.5) | 7.6 (3.8) | 8.2 (3.9) | 6.1 (2.1) | 6.1 (2.5) | − 1.6 (− 2.6, − 0.6)‡ | − 1.97 (− 3.0, − 0.9)‡ |
Bone turnover markers | ||||||||
Serum P1NP (μg/L) | 44.8 (16.0) | 47.1 (17.4) | 49.0 (26.0) | 46.3 (25.0) | 46.6 (17.9) | 47.6 (26.5) | − 1.0 (− 6.0, 4.0) | − 1.5 (− 3.0, 2.7) |
Serum CTX-1 (μg/L) | 0.19 (0.10) | 0.20 (0.10) | 0.19 (0.13) | 0.20 (0.11) | 0.20 (0.10) | 0.21 (0.11) | − 0.01 (− 0.05, 0.02) | − 0.004 (− 0.04, 0.03) |
10 and 25 μg doses separately.
Corrected for serum albumin.
n = 69 for placebo, 68 for 10 and 74 for 25 μg group.
Difference in change comparing to placebo.
P < 0.001, PTH difference between placebo in 10 μg group, P = 0.002.