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- Title
Clodronate as a Single-dose Intravenous Infusion Effectively Provides Short-term Correction of Malignant Hypercalcemia.
- Authors
Atula, Sari T.; Tähtelä, Riitta K.; Nevalainen, Jaakko I.; Pylkkänen, Liisa H.
- Abstract
The efficacy and safety of a single intravenous (I.V.) infusion of clodronate 1 500 mg or 900 mg was compared with a single I.V. infusion of pamidronate 90 mg in the treatment of malignant hypercalcemia. Primary efficacy data from two separate, but parallel, randomized double-blind controlled multi-center studies (N=63), involving patients with malignant hypercalcemia (S-Ca cor >2.68 mmol/l), were pooled along with results from a study (N=4), in which an open I.V. phase was followed by a randomized oral phase. The primary efficacy variable, the proportion of normocalcemic patients at day 5 could be evaluated from 51 subjects. Of them, 21 were in the clodronate 1 500 mg group, 10 in the clodronate 900 mg group and 20 in the pamidronate 90 mg group. After the rehydration, the patients were given a single I.V. infusion of clodronate 1 500 mg, clodronate 900 mg or pamidronate 90 mg. The patients were followed up for five days and S-Ca cor was measured daily. At day 5, a total of 16 patients (76%) in the clodronate 1 500 mg group, six patients (60%) in the clodronate 900 mg group and 17 patients (85%) in the pamidronate 90 mg group were normocalcemic, the differences between the treatment groups being statistically non-significant. The differences in the mean S-Ca cor between the treatment groups were statistically non-significant. I.V. clodronate given either as 900 mg or 1 500 mg single-dose was safe and well tolerated.
- Subjects
INTRAVENOUS therapy; HYPERCALCEMIA; CLINICAL trials; DRUG efficacy; THERAPEUTICS
- Publication
Acta Oncologica, 2003, Vol 42, Issue 7, p735
- ISSN
0284-186X
- Publication type
Article
- DOI
10.1080/02841860310013111