Table 1.

Summary of randomized controlled trials of risedronate for the treatment of male osteoporosis

Condition	Design	n	RIS dose (mg)	BMD LS (%)	BMD FN (%)	Vert fracture	Hip fracture
Primary OP (Boonen 2006) 24 months	RCT	191	35 per wk	4.5	NR	NR	NR
		93	Pla	NR	NR	NR	NR
Primary and Secondary OP (Ringe 2003) 12 months	RCT	158	5 per day	4.7	1.8	5.1%	NR
		158	Pla	1.0	0.2	12.7%	NR
CIOP prevention (Reid 2000, 2001) 12 months	RCT	184	2.5 or 5 perday	0.8a	1.5a	Ris 9% Pla 24%	NR
			Pla	−3.4	−3.3	Pooled	NR
CIOP treatment (Reid 2001; Cohen 1999) 12 months			2.5 or 5 perday	4.8a	2.1a	2.5/5 mg vs placebo 82.4% reduction (p = 0.008)	NR
			Pla	1.2	−0.2		NR
Post-stroke (Sato 2005) 18 months	RCT	140	2.5/day	2.5b	NR	NR	1.4
		140	Pla	−3.5b	NR	NR	7.1
Hyperthyroidism (Majima 2006) 12 months	RCT	14	2.5	6.07	4.41	NR	NR
		13	Pla	1.90	2.61	NR	NR
IBD (Henderson 2006) 12 months	RCT	total 61	5	2.9	3.1	NR	NR
		male 25	Pla	1.04	0.1	NR	NR
Transplantation (Tauchmanova 2003) 12 months	RCT	total 34	5	5.9	1.3	NR	NR
		male 16	Pla	1.1	−4.2	NR	NR
Leprosy (Kanaji 2006) 9 months	RCT	12	2.5	4.8c	NR	0.82**	NR
		11	Pla	0.9c	NR	1.88	NR
Stress fractures (Milgrom 2004) 3 months	RCT	165	30 for 2 weeks then 30 weekly	N/A	N/A	N/A	14.5
		159	Pla	N/A	N/A	N/A	13.2

^aBMD change with 5 mg dose

^bmetacarpal BMD

^cestimate from graph

^**p < 0.05

Abbreviations: BMD, bone mineral density; CIOP, corticosteroid-induced osteoporosis; IBD, inflammatory bowel disease; NR, not reported; OP, osteoporosis; Pla, placebo; RIS, risedronate; RCT, randomized controlled trial.