Table 2.

Incidences of the primary and secondary endpoints in each treatment group and their rate ratios between the treatment groups at 72 weeks

	Teriparatide				Alendronate				Rate ratio*	95% CI	P
	Count	Person	Person-years	Annual incidence rate	Count	Person	Person-years	Annual incidence rate
Primary endpoint
Morphometric vertebral fracture	56	45	419.9	0.1334	96	73	553.6	0.1734	0.78	0.61 to 0.99	0.04
Secondary endpoints
Any fracture	71	55	469.2	0.1513	116	87	600.2	0.1933	0.83	0.60 to 1.16	0.28
Clinical vertebral fracture	6	5	419.9	0.0143	12	8	553.6	0.0217	0.70	0.23 to 2.09	0.52
Progression of vertebral fracture	30	28	419.9	0.0714	38	34	553.6	0.0686	1.11	0.76 to 1.64	0.59
Non-vertebral fracture	15	12	469.2	0.0320	20	20	600.2	0.0333	1.09	0.68 to 1.75	<0.01†
Secondary endpoints (fractures at specific skeletal sites)
Forearm	4	4	469.2	0.0085	3	3	600.2	0.0050
Humerus	0	0	469.2	0.0000	0	0	600.2	0.0000
Femur	3	3	469.2	0.0064	6	6	600.2	0.0100
Lower leg	0	0	469.2	0.0000	0	0	600.2	0.0000
Clavicle	1	1	469.2	0.0021	0	0	600.2	0.0000
Pelvis	1	1	469.2	0.0021	1	1	600.2	0.0017
Rib	2	1	469.2	0.0043	4	4	600.2	0.0067
Other	4	4	469.2	0.0085	6	6	600.2	0.0100

*Generalized estimating equation-Poisson regression adjusted for age, counts, and maximum grade of prevalent vertebral fractures, history of hip fractures, and bone mineral density as covariates and individual and institute as cluster

†Non-inferiority P-value with a pre-specified non-inferiority margin of 1.96

Abbreviation: CI confidence interval