Table 1.
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.