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

Table 1.

Characteristics of the treatment arm of GIOP clinical trials.

Study		Saag⁵	Cohen⁶	Reid⁷	Saag⁸	Reid⁹		Saag²⁶
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
Study sites		22	28	23	67	54		79
Study length (years)		1 (+1 extension)	1	1	1.5 (+1.5 extension)	1		1 (+1 extension)
Study size (patients enrolled)		561	228	290	428	288	546	290	505
Mean age (years) (56–69 years)		55	62	58	56	56	53	66	61
Postmenopausal women (%) (51–63%)		49	46	53	78	69	64	59	63
Premenopausal women (%) (1–2%)		22	20	9	2.5	0.4	4	5	10
Men (%) (35–47%)		29	34	38	20	32	32	36	27
Ethnicity (% white)		88	N/S	N/S	72	N/S		84	90
Prednisone equivalent inclusion criteria		⩾7.5 mg/day	⩾7.5 mg/day	⩾7.5 mg/day	⩾5 mg/day	⩾7.5 mg/day		⩾7.5 mg/day
Mean prednisone equivalent dose (mg)	Baseline	18	21	15	7.5 (median)	10 (median)	10 (median)	16	12
Mean prednisone equivalent dose (mg)	End of study	9	11	13	N/S	N/S	N/S	N/S	N/S
T-score inclusion criteria		N/A	N/A	N/A	T-score ⩽2.0 or ⩽1.0 with fracture	N/A	N/A	N/A	T-score ⩽2.0 or ⩽1.0 with fracture
Mean lumbar spine T-score at baseline		1.0 (g/cm²)	–0.7	–1.7	–2.5	–1.0	–1.4	–1.0	–2.0
Baseline osteoporosis defined by bone mineral density (%)		32	N/S	23	N/S	N/S	N/S	N/S	N/S
Prevalent vertebral fractures (%)	Study drug	15	30	33	30	N/S	N/S	14	26
Prevalent vertebral fractures (%)	Comparator/placebo	17	29	37	25	N/S	N/S	18	32
Calcium supplementation mg/day		800–1000	500	1000	1000	1000		1000
Vitamin D supplementation IU/day		250–500	None	400	800	400–1200		800
Underlying conditions (%)	Rheumatoid arthritis (23%)	30	40	40	48	38	13	33	43
	PMR/GCA (22%/6%)	23	34	18	4	20	5	35	7
	SLE (N/S)	19	15	8	12	9	16	2	6
	Asthma or COPD (19%)	10	4	20	13	4	8	2	11
	Sarcoidosis (N/S)	3	N/S	N/S	N/S	N/S	N/S	0	2
	IBD (5%)	5	N/S	N/S	2	N/S	N/S	N/S	N/S
	Neurologic diseases (6%)	7	1	3	N/S	N/S	N/S	1	5
	Skin disorders (5%)	7	N/S	N/S	N/S	N/S	N/S	3	3

COPD, chronic obstructive pulmonary disease; GCA, giant cell arteritis; GIOP, glucocorticoid-induced osteoporosis; IBD, inflammatory bowel diseases; N/A, not applicable; N/S, not specified; IU, international units; PMR, polymyalgia rheumatica; SLE, systemic lupus erythematosus.

Prevention design refers to participants on glucocorticoids for up to 3 months; treatment designation refers to participants on glucocorticoids for ⩾3 months. In square brackets expected characteristics for the glucocorticoid users in the general population (epidemiological data by Overman and colleagues¹ and Walsh and colleagues³¹).