Effect of 2 mg Versus 4 mg of Intravenous Zoledronic Acid on Bone Mineral Density at the Lumbar Spine in Indian Postmenopausal Women with Osteoporosis: A Double-blind Parallel-arm Randomized Controlled Trial.

IF 0.8 Q4 PHARMACOLOGY & PHARMACY

Journal of Research in Pharmacy Practice Pub Date : 2021-08-03 eCollection Date: 2021-04-01 DOI:10.4103/jrpp.JRPP_20_130

Harsh Durgia, Sadishkumar Kamalanathan, Govindarajalou Ramkumar, Sonali Sarkar, Sagili Vihaya Bhaskar Reddy, Jayaprakash Sahoo, Rajan Palui, Henith Raj

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引用次数: 1

Abstract

Objective: The primary purpose was to compare the effect of 2 mg and 4 mg of intravenous zoledronic acid (ZA) on change in the lumbar spine (LS) bone mineral density (BMD) at the end of 1 year in postmenopausal women with osteoporosis. The secondary objectives were changes in BMD at the total hip and femoral neck, change in bone turnover markers (BTMs), and the incidence of new fractures.

Methods: This was a double-blind, parallel-arm, randomized control trial with an allocation ratio of 1:1 done in 70 postmenopausal women with osteoporosis.

Findings: The mean (±standard deviation) percentage increase in LS BMD at the end of 1 year was 4.86% ± 3.05% and 5.35% ± 3.73% in the 2 mg and 4 mg group, respectively. The dose of 2 mg ZA proved to be inferior to 4 mg with a noninferiority margin of 0.5%. There was no difference in BMD change at hip and BTMs between the two groups at the end of 1 year. Only one patient in 4 mg group developed two new vertebral fractures during a 12-month follow-up. Acute-phase reactions were the most common (43%) side-effects noted without any difference between the two groups (P = 0.63).

Conclusion: This study failed to show the noninferiority of 2 mg ZA compared to 4 mg ZA for change in LS BMD at the end of 1 year.

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静脉注射2mg与4mg唑来膦酸对印度绝经后骨质疏松症妇女腰椎骨密度的影响:一项双盲平行随机对照试验

目的:主要目的是比较静脉注射2 mg和4 mg唑来膦酸(ZA)对绝经后骨质疏松症妇女1年后腰椎(LS)骨密度(BMD)变化的影响。次要目标是全髋关节和股骨颈的骨密度变化，骨转换标志物(BTMs)的变化以及新骨折的发生率。方法:这是一项双盲、平行组、随机对照试验，分配比例为1:1，在70名绝经后骨质疏松症妇女中进行。结果:2 mg和4 mg组1年后LS骨密度的平均(±标准差)百分比分别为4.86%±3.05%和5.35%±3.73%。2mg ZA的剂量低于4mg，非劣效边际为0.5%。1年后，两组患者髋部骨密度变化及btm无差异。在12个月的随访中，4mg组只有1例患者出现了两次新的椎体骨折。急性期反应是最常见的副作用(43%)，两组间无差异(P = 0.63)。结论:本研究未能显示2 mg ZA与4 mg ZA在1年后对LS BMD变化的非劣效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Research in Pharmacy Practice PHARMACOLOGY & PHARMACY-

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审稿时长

21 weeks

期刊介绍： The main focus of the journal will be on evidence-based drug-related medical researches (with clinical pharmacists’ intervention or documentation), particularly in the Eastern Mediterranean region. However, a wide range of closely related issues will be also covered. These will include clinical studies in the field of pharmaceutical care, reporting adverse drug reactions and human medical toxicology, pharmaco-epidemiology and toxico-epidemiology (poisoning epidemiology), social aspects of pharmacy practice, pharmacy education and economic evaluations of treatment protocols (e.g. cost-effectiveness studies). Local reports of medication utilization studies at hospital or pharmacy levels will only be considered for peer-review process only if they have a new and useful message for the international pharmacy practice professionals and readers.