TABLE 2.

Primary and secondary outcomes Bone mineral measurements at screening, 9 and 18 month DXA and their changes per ARM

	CALCITONIN		PLACEBO
	N	Mean (SD)	N	Mean (SD)	p
TOTAL BODY
Screening to 18 mos
ZTBBMDscreening	30	−1.27 (0.92)	32	−1.24 (0.75)	0.89
ZTBBMD18	23	−1.45 (0.9)	26	−1.29 (0.82)	0.53
ΔZTBBMD(18-0)	22	−0.21 (0.59)	26	0.00 (0.51)	0.3
Screening to 9 mos
ZTBBMD9	23	−1.4 (0.87)	23	−1.24 (0.92)	0.56
ΔZTBBMD(9-0)	22	−0.1 (0.51)	23	0.02 (0.5)	0.63
Screening to 18 mos (bone age adjusted)
ZTBBMD (BA)screening	28	−0.95 (1.01)	27	−0.93 (0.78)	0.96
ZTBBMD (BA)18	21	−0.9 (0.94)	20	−1.05 (0.84)	0.58
ΔZTBBMD(BA)(18-0)	21	−0.13 (0.69)	21	−0.21 (0.62)	0.71
SPINE
Screening to 18 mos
ZSBMDscreening	31	−1.55 (0.69)	32	−1.53 (0.75)	0.95
ZSBMD18	26	−1.34 (0.66)	29	−1.33 (0.87)	0.89
ΔZSBMD(18-0)	26	0.19 (0.53)	29	0.18 (0.5)	0.95
Screening to 9 mos
ZSBMD9	23	−1.44 (0.56)	23	−1.52 (0.8)	0.69
ΔZSBMD(9-0)	23	0.17 (0.38)	23	0.00 (0.49)	0.18
Screening to 18 mos (bone age adjusted)
ZSBMD (BA)screening	29	−1.28 (0.68)	27	−1.16 (0.87)	0.57
ZSBMD(BA)18	21	−0.92 (0.64)	19	−1.17 (0.87)	0.3
ΔZSBMD(BA)(18-0)	21	0.31 (0.62)	21	0.03 (0.72)	0.18

SD: standard deviation, ZTBBMD: Total body BMD Z-score, ΔZTBBMD: change in total body BMD Z-score from screening to 9 or 18 mos, ZSBMD: Spine BMD Z-score, ΔZTBBMD: change in spine BMD Z-score from screening to 9 or 18 mos, (BA): adjusted for bone age Italicized: primary outcomes