Table 2.

Clinical endpoint data.

	4-weekly	12-weekly	Estimated Difference (95% CI)
N	133	130
First SSE
N (%) SSE	44 (33.1)	44 (33.9)	0.8 (-10.6, 12.2)
Radiotherapy to bone	34 (25.6)	33 (25.4)	−0.2 (-10.7, 10.4)
Pathological fracture	3 (2.3)	5 (3.8)	1.6 (-2.6, 5.8)
Surgery to bone	2 (1.5)	0 (0)	−1.5 (-3.6, 0.6)
Spinal cord compression	1 (0.8)	2 (1.5)	0.8 (-1.8, 3.4)
Hypercalcaemia	4 (3.0)	4 (3.1)	0.1 (-4.1, 4.2)
Time to first study SSE
1-year cumulative incidence of SSE (95% CI)	17.7 (11.7, 24.8)	16.7 (10.8, 23.8)	0.96 (0.63, 1.47)**
2-year cumulative incidence of SSE (95% CI)	32.7 (24.6, 41.1)	28.1 (20.3, 36.4)
Toxicity
Osteonecrosis of the jaw	1 (0.8)	1 (0.8)	0.0 (-2.1, 2.1)
Renal impairment	7 (5.3)	8 (6.2)	0.9 (-4.7, 6.5)
Symptomatic hypocalcaemia	4 (3.0)	3 (2.3)	−0.7 (-4.6, 3.2)
Any Above Toxicity	11 (8.3)	12 (9.2)	1.0 (3.5, 7.8)
Hospitalization due to bone metastases
Hospitalization due to bone metastases	9 (6.8)	5 (3.9)	−2.9 (-8.3, 2.5)
Change in BTA dosing***
N (%) Any Change	63 (47.4)	32 (24.6)	−22.8 (-34.0, −11.5)
Discontinuation	33 (24.8)	23 (17.7)	−7.1 (-17.0, 2.7)
Change to 4-weekly dosing	–	5 (3.9)	–
Change to 12-weekly dosing	28 (21.1)	–	–
Pamidronate to denosumab	0 (0)	1 (0.8)	0.8 (-0.7, 2.2)
Pamidronate to zoledronate	3 (2.3)	0 (0)	−2.3 (-4.8, 0.3)
Zoledronate to pamidronate	1 (0.8)	0 (0)	−0.8 (-2.2, 0.7)
Zoledronate to denosumab	1 (0.8)	0 (0)	−0.8 (-2.2, 0.7)
Missed Dose(s)	15 (11.3)	6 (4.6)	−6.7 (-13.1, −0.2)

SSE = symptomatic skeletal related event, SMR = skeletal mobility rate, * = risk difference,** = hazard ratio for 12-weekly versus 4-weekly

NOTE: that the number of patients with at least 1 SSE is over any time period (including beyond 2 years), hence does not equal the number of patients with a SSE within 2 years

*** Patients may have experienced multiple changes in dosing