Table 4.

Comparison of median change from baseline to month 6 between arms by 25 OHD status at baseline

25OHD	N	TDF/FTC once daily + Oskept® twice daily		N	TDF/FTC once daily		p‐value**
		Median (IQR)	p‐value*		Median (IQR)	p‐value*
LSBMD
<20	13	0.05 (0 to 0.05)	0.51	17	0.03 (0 to 0.03)	0.23	0.04
>20	25	0.04 (0 to 0.06)		25	0.02 (0 to 0.03)		0.31
LSBMD Z‐score
<20	13	0.30 (0.20 to 0.50)	0.27	17	0.20 (0 to 0.40)	0.25	0.13
≥20	25	0.20 (0.05 to 0.50)		25	0.10 (−0.10 to 0.20)		0.39
25 OHD (ng/mL)
<20	13	1.5 (−0.6 to 3.8)	0.27	17	0.5 (−2.4 to 3)	0.02	0.25
≥20	25	−1.5 (−5.3 to 2.4)		25	−2.3 (−4.1 to −0.55)		0.95
iPTH (pg/mL)
<20	13	7.3 (−5.1 to 12.8)	0.99	17	3.8 (−8.2 to 22.3)	0.79	0.76
≥20	25	4.6 (−1.8 to 14.4)		25	7.8(−5.3 to 18.1)		0.92

25 OHD, 25 hydroxyvitaminD; iPTH, intact parathyroid hormone; LSBMD, lumbar spine bone mineral density.

^* p‐value comparing arms stratified by 25OHD levels.

^** p‐value comparing median change between arms using Wilcoxon rank‐sum test.