Comparison of different dose regimes of aminohydroxypropylidene-1,1-bisphosphonate (APD) in hypercalcaemia of malignancy.

1. The new intravenous bisphosphonate drug aminohydroxypropylidine bisphosphonate (APD) is effective in treating the hypercalcaemia of malignant disease, but the optimum dose regimen is not yet established. We have treated twenty-seven patients with malignant hypercalcaemia (corrected calcium greater than 3.00 mmol l-1) with intravenous APD, comparing three regimens of drug administration. 2. Patients were randomly allocated to receive a single dose of APD 30 mg on day 1 (group A, n = 9), two consecutive doses of 30 mg on days 1 and 2 (group B, n = 9) or a single 60 mg dose on day 1 (group C, n = 9). The patients were severely hypercalcaemic, and in nine (33%) the corrected serum calcium was higher than 4.00 mmol l-1 and all were severely ill: three patients died within 48 h of receiving the initial dose and seven died within the first week. 3. Serum calcium levels fell by day 7 in all patients: in group A, from 3.91 +/- 0.40 (s.d.) mmol l-1 to 2.91 +/- 0.49; in group B, from 3.59 +/- 0.33 to 2.63 +/- 0.23 mmol l-1; and in group C, from 3.71 +/- 0.43 to 2.66 +/- 0.39 mmol l-1. Complete response, defined by a nadir calcium (on days 5-12) below 2.60 mmol l-1 occurred in eleven of 24 surviving patients (4/9 in group A, 4/7 in group B, and 3/8 in group C). The remaining patients showed a partial response with serum calcium falling at least 0.25 mmol l-1.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes