Effects of zoledronic acid versus placebo on bone mineral density and bone texture analysis assessed by the trabecular bone score in premenopausal women with breast cancer treatment-induced bone loss: results of the ProBONE II substudy

Effects of zoledronic acid versus placebo on bone mineral density and bone texture analysis assessed by the trabecular bone score in premenopausal women with breast cancer treatment-induced bone loss: results of the ProBONE II substudy
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DOI:
10.1007/s00198-014-2955-3
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发表时间:
2015-01-01
影响因子:
4
通讯作者:
Hadji, P.
Hadji, P.
中科院分区:
医学2区
文献类型:
--
作者:
Kalder, M.;Kyvernitakis, I.;Hadji, P.

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在接受唑来膦酸盐(ZOL)(n = 34)或安慰剂(n = 36)治疗2年的70例患者中评估骨矿物质密度(BMD)和骨小梁评分(TBS)的变化。在绝经前妇女乳腺癌治疗引起的骨丢失,24个月的静脉注射ZOL治疗显着增加腰椎BMD和TBS。本研究的目的是比较效果的4毫克静脉注射唑来膦酸盐(ZOL)与安慰剂(PLB),每3个月,对绝经前乳腺癌(BC)治疗引起的骨丢失妇女的腰椎(LS)骨矿物质密度(BMD)和骨小梁评分(TBS)的影响。TBS是一种与骨微结构相关的灰度纹理测量,被认为与BMD无关。在双盲、安慰剂对照的ProBONE-II试验中招募了70例患者,随机接受ZOL(n = 34)或PLB(n = 36)治疗2年,评估BMD和TBS的变化。接受ZOL治疗的患者从基线到治疗12个月(2.17%)和24个月(3.14%)的LS BMD平均增加,TBS平均增加分别为2.41%和0.75%。相反,接受PLB的患者显示LS BMD从基线至12个月(-5.02%)和24个月(-6.43%)的平均降低,TBS分别平均降低-0.52%和-2.16%。从基线到12个月和24个月,ZOL与PLB相比,BMD和TBS的变化都有显著差异(p < 0.005)。此外,BMD和TBS显示出中度相关性,范围为0.28(p = 0.087)至0.47(p = 0.003)。在绝经前BC妇女中,24个月的静脉注射ZOL治疗显著增加LS BMD以及TBS。
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.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.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.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).In premenopausal women with BC, 24 months of intravenous ZOL treatment significantly increased the LS BMD as well as the TBS.