Table 4.

Efficacy analysis: change in areal BMD and areal BMD z-scores from baseline to one year (population: ITT).

Change from baseline to 1 year	Mean (SD)			p-Value	Alfacalcidol vs placebo		Risedronate vs placebo		Risedronate vs alfacalcidol
	Placebo	Alfacalcidol	Risedronate		Mean difference (95% CI)	p-Value	Mean difference (95% CI)	p-Value	Mean difference (95% CI)	p-Value
Primary outcome measure: change in lumbar spine aBMD-Z score
Primary analysis - ITT	− 0.036 (0.435)	− 0.088 (0.519)	0.238 (0.551)	0.0007	− 0.052 (− 0.257, 0.153)	1.0	0.274 (0.061, 0.487)	0.007	0.326 (0.109, 0.543)	0.001
Per protocol	− 0.043 (0.431)	− 0.036 (0.510)	0.264 (0.540)	0.0008	0.007 (− 0.204, 0.219)	1.0	0.307 (0.092, 0.521)	0.002	0.300 (0.078, 0.522)	0.004
ANCOVA				0.0004	− 0.024 (− 0.219 to 0.171)	1.0	0.286 (0.083 to 0.488)	0.002	0.311 (0.104 to 0.516)	0.001
Change in lumbar spine aBMD g/cm2
ITT	0.034 (0.047)	0.031 (0.052)	0.069 (0.057)	0.0001	− 0.002 (− 0.023, 0.019)	1.0	0.036 (0.014, 0.058)	< 0.001	0.038 (0.015, 0.060)	< 0.001
Per protocol	0.034 (0.048)	0.036 (0.051)	0.072 (0.055)	0.0001	0.002 (− 0.020, 0.024)	1.0	0.038 (0.015, 0.060)	< 0.001	0.036 (0.013, 0.059)	0.001
ANCOVA				0.0001	− 0.001 (− 0.022, 0.021)	1.0	0.036 (0.014, 0.059)	< 0.001	0.037 (0.015, 0.060)	< 0.001
Change in total body less head aBMD g/cm2
ITT	0.016 (0.032)	0.029 (0.034)	0.040 (0.030)	0.0001	0.014 (0.001, 0.027)	0.035	0.025 (0.011, 0.038)	< 0.001	0.011 (− 0.003, 0.025)	0.1
Per protocol	0.016 (0.032)	0.032 (0.034)	0.041 (0.030)	0.0001	0.015 (0.002, 0.029)	0.024	0.025 (0.011, 0.039)	< 0.001	0.010 (− 0.005, 0.024)	0.3
Change in total body less head aBMD-Z score
ITT	− 0.129 (0.458)	0.012 (0.505)	0.169 (0.415)	0.0016	0.141 (− 0.051, 0.333)	0.2	0.298 (0.101, 0.495)	0.001	0.157 (− 0.043, 0.358)	0.1
Per protocol	− 0.103 (0.448)	0.067 (0.476)	0.182 (0.415)	0.0021	0.170 (− 0.024, 0.365)	0.1	0.285 (0.090, 0.481)	0.002	0.115 (− 0.086, 0.317)	0.5