Table 1

Levels of bone biomarkers at prespecified timepoints

ParameterBaseline
(n=9)
Month 1
(n=9)
% change from baseline to month 1Month 4
(n=7)
% change from baseline to month 4
Median
(range)
Median
(range)
Median
(range)
P valuerMedian (range)Median (range)P valuer
Markers of bone turnoverCTX, ng/mL0.42 (0.13, 1.48)0.29 (0.1, 1.33)−23 (−37, 20)0.010.80.27 (0.18, 0.93)6.7 (−35, 65)0.90.03
PINP, µg/L38.7 (16.1, 73.6)32.4 (19.1, 87.2)−7.1 (−37, 26)0.20.340.8 (18.4, 83)8.4 (0, 53)0.020.8
OCN, ng/mL17.9 (6.3, 22.6)14.8 (8.7, 26.6)−2.4 (−54, 128)0.60.117.5 (4.4, 33)30 (−71, 179)0.30.3
Markers of bone metabolismCalcium, mmol/L2.37 (2.22, 2.46)2.36 (2.17, 2.46)−2.6 (−8, 10)0.20.32.34 (2.15, 2.52)−0.4 (−7, 3)0.40.2
25(OH) VitD, ng/mL30.6 (13.1, 104)31 (12.9, 118)14.9 (−8, 60)0.050.634.3 (22.1, 104)2.9 (−27, 74)0.80.06
PTH, ng/L28 (19.2, 53)27 (14, 62)0 (−56, 30)0.90.0224.8 (15, 34)−9.3 (−36, 44)0.30.3
  • CTX, C-terminal telopeptide; OCN, osteocalcin; 25(OH) Vit D, 25-hydroxy vitamin D; PINP, procollagen type I N-terminal propeptide; PTH, parathyroid hormone.