M Kalder1, I Kyvernitakis, U S Albert, M Baier-Ebert, P Hadji. 1. Department of Obstetrics and Gynecology, Philipps University of Marburg, Baldingerstrasse, 35043, Marburg, Germany, kalder@med.uni-marburg.de.
Abstract
UNLABELLED: Changes in bone mineral density (BMD) and trabecular bone score (TBS) were assessed in 70 patients who received eitherzoledronate (ZOL) (n = 34) or placebo (n = 36) for 2 years. In premenopausal women with breast cancer treatment-induced bone loss, 24 months of intravenous ZOL treatment significantly increased the lumbar spine BMD and the TBS. INTRODUCTION: The aim of this study was to compare the effects of 4 mg intravenous zoledronate (ZOL) versus placebo (PLB), every 3 months, on the lumbar spine (LS) bone mineral density (BMD) and the trabecular bone score (TBS) in premenopausal women with breast cancer (BC) treatment-induced bone loss. The TBS is a gray-level texture measurement which is related to the bone microarchitecture and considered to be independent of the BMD. METHODS: Changes in BMD and TBS were assessed in 70 patients who were recruited in the double-blind, placebo-controlled ProBONE-II trial and randomized to receive either ZOL (n = 34) or PLB (n = 36) for 2 years. The changes were assessed at baseline and at 12 and 24 months after treatment initiation. RESULTS: Patients receiving ZOL showed a mean increase in LS BMD from the baseline to 12 (2.17%) and 24 months (3.14%) of treatment and a mean increase in the TBS of 2.41 and 0.75%, respectively. Conversely, patients receiving PLB showed a mean decrease in the LS BMD from the baseline to 12 (-5.02%) and 24 (-6.43%) months and a mean decrease of -0.52 and -2.16% in the TBS, respectively. Changes in the BMD and the TBS from the baseline to 12 and 24 months were all significantly different for ZOL compared to PLB (p < 0.005). Furthermore, BMD and TBS showed a moderate correlation ranging from 0.28 (p = 0.087) to 0.47 (p = 0.003). CONCLUSIONS: In premenopausal women with BC, 24 months of intravenous ZOL treatment significantly increased the LS BMD as well as the TBS.
RCT Entities:
UNLABELLED: Changes in bone mineral density (BMD) and trabecular bone score (TBS) were assessed in 70 patients who received either zoledronate (ZOL) (n = 34) or placebo (n = 36) for 2 years. In premenopausal women with breast cancer treatment-induced bone loss, 24 months of intravenous ZOL treatment significantly increased the lumbar spine BMD and the TBS. INTRODUCTION: The aim of this study was to compare the effects of 4 mg intravenous zoledronate (ZOL) versus placebo (PLB), every 3 months, on the lumbar spine (LS) bone mineral density (BMD) and the trabecular bone score (TBS) in premenopausal women with breast cancer (BC) treatment-induced bone loss. The TBS is a gray-level texture measurement which is related to the bone microarchitecture and considered to be independent of the BMD. METHODS: Changes in BMD and TBS were assessed in 70 patients who were recruited in the double-blind, placebo-controlled ProBONE-II trial and randomized to receive either ZOL (n = 34) or PLB (n = 36) for 2 years. The changes were assessed at baseline and at 12 and 24 months after treatment initiation. RESULTS:Patients receiving ZOL showed a mean increase in LS BMD from the baseline to 12 (2.17%) and 24 months (3.14%) of treatment and a mean increase in the TBS of 2.41 and 0.75%, respectively. Conversely, patients receiving PLB showed a mean decrease in the LS BMD from the baseline to 12 (-5.02%) and 24 (-6.43%) months and a mean decrease of -0.52 and -2.16% in the TBS, respectively. Changes in the BMD and the TBS from the baseline to 12 and 24 months were all significantly different for ZOL compared to PLB (p < 0.005). Furthermore, BMD and TBS showed a moderate correlation ranging from 0.28 (p = 0.087) to 0.47 (p = 0.003). CONCLUSIONS: In premenopausal women with BC, 24 months of intravenous ZOL treatment significantly increased the LS BMD as well as the TBS.
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