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苄氟噻嗪对骨密度的影响;BONATHIAD随机双盲安慰剂对照队列研究结果

Effects of bendroflumethiazide on bone mineral density; results from the BONATHIAD randomized double-blind placebo-controlled cohort study.

作者信息

Emmanuel Thomas, Kruse Christian, Leere Julius Simoni, Poulsen Trine Holmgaard, Vestergaard Peter

机构信息

Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark.

Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark.

出版信息

Bone Rep. 2020 Nov 25;13:100737. doi: 10.1016/j.bonr.2020.100737. eCollection 2020 Dec.

Abstract

PURPOSE

Thiazide diuretics (TD) may play a role in preventing osteoporosis. The objective was to investigate the effects of bendroflumethiazide in combination with bisphosphonates on bone mineral density, selected blood parameters, blood pressure, pulse, and muscle function.

METHODS

Double-blinded, randomized, placebo-controlled interventional study in postmenopausal osteoporotic women over the age of 50 years consisting of four arms: 1) 24 weeks with bendroflumethiazide +24 weeks of washout, 2) 24 weeks with placebo +24 weeks of washout, 3) 48 weeks with bendroflumethiazide, or 4) 48 weeks with placebo. At inclusion, participants were on oral bisphosphonates. Intervention consisted of either bendroflumethiazide or placebo. Dual energy X-ray absorptiometry (DXA), vertebral fracture assessment (VFA), quantitative CT (QCT) and selected blood parameters were acquired at baseline and at 48 weeks and Timed-Up-and-Go, handgrip strength, blood pressure, pulse and balance additionally at 24 weeks.

RESULTS

139 postmenopausal Caucasian women over 50 years were randomized (mean age 64.7 years (SEM 0.6, range 51-79)). 109 (78%) completed the study. No difference in the effect of bendroflumethiazide on DXA, VFA, QCT, biochemistry or muscle function were found between the treatment arms.

CONCLUSION

Bendroflumethiazide for 24- or 48 weeks in combination with bisphosphonates does not improve bone mineral density, selected blood parameters or muscle function compared to placebo combined with bisphosphonates. Studies with longer treatment periods and more patients are needed to further characterize the effects of bendroflumethiazide on bone and subpopulations that might benefit from the treatment.

摘要

目的

噻嗪类利尿剂(TD)可能在预防骨质疏松症中发挥作用。本研究旨在探讨苄氟噻嗪与双膦酸盐联合使用对骨密度、选定血液参数、血压、脉搏和肌肉功能的影响。

方法

对50岁以上绝经后骨质疏松女性进行双盲、随机、安慰剂对照干预研究,分为四组:1)服用苄氟噻嗪24周+洗脱期24周;2)服用安慰剂24周+洗脱期24周;3)服用苄氟噻嗪48周;4)服用安慰剂48周。入组时,参与者正在服用口服双膦酸盐。干预措施为苄氟噻嗪或安慰剂。在基线和48周时进行双能X线吸收法(DXA)、椎体骨折评估(VFA)、定量CT(QCT)和选定血液参数检测,并在24周时额外检测计时起立行走测试、握力、血压、脉搏和平衡能力。

结果

139名50岁以上绝经后白人女性被随机分组(平均年龄64.7岁(标准误0.6,范围51 - 79岁))。109名(78%)完成了研究。各治疗组之间苄氟噻嗪对DXA、VFA、QCT、生化指标或肌肉功能的影响无差异。

结论

与双膦酸盐联合使用安慰剂相比,苄氟噻嗪联合双膦酸盐治疗24周或48周并未改善骨密度、选定血液参数或肌肉功能。需要进行更长治疗期和更多患者的研究,以进一步明确苄氟噻嗪对骨骼的影响以及可能从该治疗中获益的亚组人群。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8089/7723776/1dc7ea683f81/gr1.jpg

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