Intravenous Zoledronate 4 mg for the treatment of post-menopausal osteoporosis: A prospective open-labeled study

Abstract

BackgroundZoledronate 5 mg intravenous (IV) annually is approved for treatment of post-menopausal osteoporosis. Zoledronate 4 mg which is approved for the treatment of cancer related hypercalcemia can be an alternative for Asian women who have smaller stature. ObjectivesTo examine the efficacy and safety of Zoledronate 4 mg IV annually for the treatment of post-menopausal osteoporosis. MethodA prospective open-labeled study was performed on 33 post-menopausal osteoporosis patients. All patients received a dose of IV Zoledronate 4 mg. Bone mineral density (DXA) was examined at baseline and 12 months after treatment. Beta-C-terminal telopeptide (β-CTX) and procollagen type-1-amino-terminal propeptide (P1NP) were obtained at baseline, 6, and 12 months after treatment. Adverse events were recorded. ResultsThe mean age (SD) was 69 (11.1) years old. The lumbar spine BMD increased significantly from the mean (SD) lumbar spine BMD at baseline of 0.833 (0.132) g/cm2 to 0.862 (0.132) after treatment (p = 0.001). There was no significant differences in total hip and femoral neck BMDs between baseline and 12 months after treatment. The β-CTX and P1NP decreased significantly from the mean (SD) of 0.44 (0.24) and 55.57 (38.6) ng/ml at baseline to 0.21 (0.11) and 27.26 (10.95) ng/ml after treatment (p < 0.001), respectively. Infusion reaction was observed in five patients. There were two fractures observed. ConclusionZoledronate 4 mg improved lumbar BMD and decreased β-CTX and P1NP significantly after 12 months of treatment. Zoledronate 4 mg could be an alternative to Zoledronate 5 mg for the treatment of post-menopausal osteoporosis.