. 2019 Sep 20;11:1759720X19876468. doi: 10.1177/1759720X19876468

Table 2.

Outcomes of GIOP clinical trials.

Study			Saag⁵	Cohen⁶	Reid⁷	Saag⁸	Reid⁹		Saag¹⁰
Study drug			Alendronate	Risedronate	Risedronate	Teriparatide	Zoledronic acid		Denosumab
Comparator			Placebo	Placebo	Placebo	Alendronate	Risedronate		Risedronate
Design			Treatment	Prevention	Treatment	Treatment	Prevention	Treatment	Prevention	Treatment
Lumbar spine change (%)	From baseline		+2.9	+0.6	+2.9	+7.2	+4.1	+2.6	+3.8	+4.4
Lumbar spine change (%)	From comparator/placebo		+3.3	+3.4	+2.5	+3.8	+1.4	+2.0	+3.0	+2.1
Total hip change (%)	From baseline		+2.7	+1.4	+2.4	N/A	+2.0	+2.8	+1.7	+2.1
Total hip change (%)	From comparator/placebo		+3.4	+4.4	+1.4	N/A	+1.4	+2.3	+1.5	+1.5
Femoral neck change (%)	From baseline		+1.0	+0.8	+1.8	N/A	+1.4	+1.3	+0.9	+1.6
Femoral neck change (%)	From comparator/placebo		+2.2	+3.8	+2.1	N/A	+1.0	+1.3	+1.1	+1.0
New vertebral fractures (%)	Study drug		2.3	5.7	5	0.6	1.3		3.0
New vertebral fractures (%)	Comparator/placebo		3.7	17.3	15	6.1	0.8		4.4
New non-vertebral fractures (%)	Study drug		4.4	3.9	8	5.6	N/S		4
New non-vertebral fractures (%)	Comparator/placebo		4.4	5.9	6	3.7	N/S		3
Vertebral fracture risk reduction (%)			38 (ns)	67 (ns)	67 (ns)	90 (p < 0.01)	N/A		31 (ns)
Number needed to treat to avoid a vertebral fracture			71	9	10	18	N/A		71
Adverse events (% of patients enrolled)	Overall	Study drug	83	N/S	98	85	77	78	72
Adverse events (% of patients enrolled)	Overall	Comparator/placebo	79	N/S	98	79	65	68	69
	Serious	Study drug	21	23	39	21	18	20	16
	Serious	Comparator/placebo	19	26	37	18	16	18	17
	Withdrawn	Study drug	4	4	11	N/S	1	4	6
	Withdrawn	Comparator/placebo	5	5	12	N/S	1	2	8

GIOP, glucocorticoid-induced osteoporosis; N/A, not applicable; N/S, not specified; ns, non-significant.

Prevention design refers to participants on glucocorticoids for up to 3 months; treatment designation refers to participants on glucocorticoids for ⩾3 months.