Table 1. Summary of major randomized... | American Society of Hematology

Table 1.

Summary of major randomized clinical trials on bone-targeting agents for treatment of MBD

Study	Treatment drug	Treatment schedule	Patients, n	Median time to first SRE, mo	SRE incidence, %	ONJ incidence, %	Renal toxicity, %
52	Pamidronate vs placebo	90 mg of pamidronate every 4 wk for 9 cycles	196 vs 181	Shorter in placebo group (P = .001)	24 vs 41 (P < .001)	NR	NR
53	ZA vs pamidronate	4 or 8 mg of ZA IV or 90 mg of IV pamidronate every 3-4 wk for 12 mo	129 vs 65	12.5 vs 9.4	NR	NR	NR
54	Pamidronate	30 vs 90 mg of pamidronate	252 vs 252	10.2 vs 9.2 (P = .63)	33.7 vs 35.2	0.8 vs 3.2	NR
55,56	ZA vs clodronate	4 mg of ZA IV every 3-4 wk or 1600 mg of clodronic acid orally daily	981 vs 979	NR	27 vs 35 (P = .0004)	4 vs <1	Similar for 2 treatment groups (P = .55)
57	ZA	ZA every 12 vs every 4 wk	139 vs 139	NR	55 vs 60	NR	NR
58	Denosumab vs ZA	120 mg of denosumab sc plus placebo IV or ZA 4 mg IV plus placebo sc every 4 wk	859 vs 859	22.8 vs 24 (P_{noninferiority} = .01)	43.8 vs 44.6	4.1 vs 2.8	10 vs 17.1

Study	Treatment drug	Treatment schedule	Patients, n	Median time to first SRE, mo	SRE incidence, %	ONJ incidence, %	Renal toxicity, %
52	Pamidronate vs placebo	90 mg of pamidronate every 4 wk for 9 cycles	196 vs 181	Shorter in placebo group (P = .001)	24 vs 41 (P < .001)	NR	NR
53	ZA vs pamidronate	4 or 8 mg of ZA IV or 90 mg of IV pamidronate every 3-4 wk for 12 mo	129 vs 65	12.5 vs 9.4	NR	NR	NR
54	Pamidronate	30 vs 90 mg of pamidronate	252 vs 252	10.2 vs 9.2 (P = .63)	33.7 vs 35.2	0.8 vs 3.2	NR
55,56	ZA vs clodronate	4 mg of ZA IV every 3-4 wk or 1600 mg of clodronic acid orally daily	981 vs 979	NR	27 vs 35 (P = .0004)	4 vs <1	Similar for 2 treatment groups (P = .55)
57	ZA	ZA every 12 vs every 4 wk	139 vs 139	NR	55 vs 60	NR	NR
58	Denosumab vs ZA	120 mg of denosumab sc plus placebo IV or ZA 4 mg IV plus placebo sc every 4 wk	859 vs 859	22.8 vs 24 (P_{noninferiority} = .01)	43.8 vs 44.6	4.1 vs 2.8	10 vs 17.1

NR, not reported; ONJ, osteonecrosis of the jaw; sc, subcutaneously; ZA, zoledronic acid.