Table 3.

Change from baseline in bone micro-architecture parameters evaluated by HR-pQCT (full analysis set)

	Month	csDMARDs plus denosumab (N = 21)		csDMARD therapy alone (N = 22)		Difference (csDMARDs plus denosumab − csDMARD therapy alone)
		n	Adjusted mean [95% CI]	n	Adjusted mean [95% CI]	Adjusted mean [95% CI] P value
vBMD of the 2–3 metacarpal heads, %	6	42	4.57 [2.12, 7.03]	44	2.17 [− 0.39, 4.74]	2.40 [− 0.29, 5.10] P = 0.0791
	12	38	6.90 [4.37, 9.43]	42	2.87 [0.29, 5.45]	4.03 [1.28, 6.78] P = 0.0049
BV/TV of the 2–3 metacarpal heads, %	6	42	3.88 [1.98, 5.77]	44	1.77 [− 0.21, 3.76]	2.11 [0.03, 4.19] P = 0.0473
	12	38	5.41 [3.45, 7.36]	42	2.31 [0.31, 4.31]	3.10 [0.97, 5.22] P = 0.0050
Tb.Th of the 2–3 metacarpal heads, %	6	42	1.51 [0.24, 2.78]	44	0.51 [– 0.81, 1.83]	1.00 [− 0.47, 2.46] P = 0.1799
	12	38	2.37 [1.02, 3.71]	42	0.80 [− 0.53, 2.12]	1.57 [0.06, 3.09] P = 0.0421
Tb.Sp of the 2–3 metacarpal heads, %	6	42	− 2.46 [− 5.89, 0.98]	44	0.38 [− 3.15, 3.92]	− 2.84 [− 6.67, 0.99] P = 0.1431
	12	38	− 2.18 [− 5.78, 1.41]	42	1.95 [− 1.61, 5.51]	− 4.14 [− 8.07, − 0.20] P = 0.0397

Data are shown as adjusted mean [95% CI] unless otherwise indicated

n is the number of joints evaluated

For adjusted mean, a linear mixed effect model analysis was performed using treatment group, sex, anti-CCP antibody (positive vs negative), baseline DAS28-ESR, measurement time point, and the interaction between the treatment group and measurement time point as fixed effects; patients as random effects; and baseline values as covariates

BV/TV trabecular bone volume fraction, CCP cyclic citrullinated peptide, CI confidence interval, csDMARD conventional synthetic disease-modifying anti-rheumatic drug, DAS28-ESR Disease Activity Score in 28 joints for rheumatoid arthritis with erythrocyte sedimentation rate, HR-pQCT high-resolution peripheral quantitative computed tomography, Tb.Sp trabecular separation, Tb.Th trabecular thickness, vBMD volumetric bone mineral density