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. 2005 Apr 2;330(7494):769–773. doi: 10.1136/bmj.330.7494.769

Table 1.

Studies of intravenous 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)
Ibandronate2 466 Life expectancy >60 weeks 66-69% Skeletal morbidity period rate* Ibandronate 6 mg: 1.19 (0.004)
Ibandronate 2 mg: 1.31 (0.152) Placebo: 1.48
Pamidronate3 754 Life expectancy >9 months 64-66% Skeletal morbidity rate (+hypercalcaemia of malignancy) Pamidronate 90 mg: 2.5 (<0.001) Placebo: 4.0
Pamidronate4 404 Life expectancy at least 3 months 54-57% Cumulative skeletal symptom events Pamidronate 60 mg: 200 (0.0042) Placebo: 278
Pamidronate5 372 Life expectancy at least 9 months 66-72% Skeletal morbidity rate Pamidronate 90 mg: 2.4 (0.008) Placebo: 3.8
Pamidronate6 382 Life expectancy at least 9 months 60-62% Proportion of patients in whom any skeletal related event occurred Pamidronate 90 mg: 43% (0.008) Placebo: 56%
Pamidronate7 295 N/A 52-58% Progression of disease in bone (days)
Pamidronate45 mg: 249 (0.02) No bisphosphonate: 168
Marked pain reduction (%) Pamidronate 45mg: 44% (0.025) No bisphosphonate: 30%

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.