Phase II clinical trial of home-made incadronate in patients with pain of bone metastasis of malignancy or/and hypercalcemia

Objective: To evaluate the efficacy and safety of home-made incadronate in treatment of patients with pain of bone metastasis of malignancy or/and hypercalcemia.Methods: A randomized,parallel comparative trial was performed on 212 patients with pain of bone metastasis of malignancy.The patients were randomized into test group(incadronate 10 mg+0.9% sodium chloride injection 500 mL,iv,2-4 h) and control group(pamidronate sodium 90 mg+0.9% sodium chloride injection 500 mL,iv,3 h).Each group had 106 patients.The efficacy and the toxicity of incadronate and pamidronate sodium were observed.The open trial was done in patients with malignancy-associated hypercalcemia.Results: The rate of pain relief was 70.19% and the response rate of Karnofsky performance status(KPS) improvement was 50.96% in the test group.There were no significant differences between the two groups in pain relief and KPS improvement.The levels of serum calcium of 6 patients with malignancy-associated hypercalcemia were decreased to the normal after using incadornate.The incidence of adverse events was 26.42% in the test group and 46.23% in control group(P0.01).The main symptom was slight or moderate fever.The test group had a significantly lower incidence of fever.Conclusion: Home-made incadornate is a kind of effective drug in the treatment of patients with pain of bone metastasis of malignancy or/and hypercalcemia.