Table 2.

Studies of oral bisphosphonate compared with placebo or no treatment

Bisphosphonate	No of patients	Eligibility criteria	% of patients with bone only disease enrolled in study	Primary end point	Results (P value of difference from placebo or control)
Ibandronate8	435	Life expectancy >60 weeks	N/A	Skeletal morbidity period rate*	Ibandronate 20 mg: 0.97 (0.024)
					Ibandronate 50 mg: 0.98 (0.037) Placebo: 1.20
Ibandronate9	564	Life expectancy >60 weeks	N/A	Skeletal morbidity period rate	Ibandronate 50 mg: 0.99 (0.041) Placebo: 1.15
Clodronate10	144	N/A	N/A	Time to new bone event (days)	Clodronate 1600 mg: 244 (0.05) Placebo: 180
Clodronate11	100	Life expectancy >6 months	N/A	No of skeletal related events	Clodronate 1600 mg: 14/49 (N/A) Control: 21/51
Clodronate12	173	N/A	18-32%	Mean skeletal morbidity rate†	Clodronate 1600 mg: 218.6 (<0.001) Placebo: 304.8
Pamidronate13	161	Life expectancy >6 months	N/A	Total No of complications	Pamidronate 300 mg: 90 (0.003) Control: 144
				Mean No of complications	Pamidronate 300 mg: 6.1 (0.02) Control: 8.1

N/A: Not available.

^*Number of 12 week periods with new skeletal complications divided by the number of periods on study.

^†Ratio of the number of skeletal complications experienced by a patient divided by the time on the trial by the end of the specified time period.