替勃龙和雷洛昔芬对≥70岁绝经后期女性维持骨骼肌力量、骨矿物质密度、平衡能力、身体成分、认知功能、情绪/抑郁、焦虑及生活质量/幸福感的疗效：一项随机、双盲、双模拟、安慰剂对照、单中心试验的研究设计

Efficacy of tibolone and raloxifene for the maintenance of skeletal muscle strength, bone mineral density, balance, body composition, cognitive function, mood/depression, anxiety and quality of life/well-being in late postmenopausal women >/= 70 years: study design of a randomized, double-blind, double-dummy, placebo-controlled, single-center trial.

作者信息

Jacobsen Didy E, Samson Monique M, van der Schouw Yvonne T, Grobbee Diederick E, Verhaar Harald J J

机构信息

Department of Geriatric Medicine, Mobility Laboratory, University Medical Center Utrecht, Utrecht, The Netherlands.

出版信息

Trials. 2008 Jun 5;9:32. doi: 10.1186/1745-6215-9-32.

DOI:10.1186/1745-6215-9-32

PMID:18533987

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2427014/

Abstract

BACKGROUND

Postmenopausal women are prone to develop functional disabilities as a result of reduction in muscle strength and muscle mass caused by diminished levels of female sex hormones. While hormone replacement therapy may counteract these changes, conventional hormone replacement therapy is associated with potential harmful effects, such as an increased risk of breast cancer, and its prescription is not recommended. For this reason newer alternative drugs, such as tibolone, a synthetic steroid with estrogenic, progestogenic and androgenic activity, and raloxifene, a selective estrogen receptor modulator, may be more appropriate. This trial investigates the effect of tibolone and raloxifene on muscle strength.

METHODS

We recruited 318 elderly women in our single-center randomized, double-blind, double-dummy, placebo-controlled trial. Participants were randomized to tibolone 1.25 mg (Org OD 14, Organon NV, the Netherlands) plus placebo, raloxifene 60 mg (Evista(R), Eli Lilly, United States) plus placebo or two placebo tablets daily for 24 months.The primary aim is to determine if there is a difference between tibolone and placebo or if there is a difference between raloxifene and placebo. Primary endpoints are muscle strength and bone mineral density. The secondary endpoints are postural balance, body composition, cognitive function, anxiety, mood and quality of life. The secondary aim is to determine if there is a difference between tibolone and raloxifene. The measure of effect is the change from the baseline visit to the visits after 3 months, 6 months, 12 months, and 24 months. A follow-up measurement is planned at 30 months to determine whether any effects are sustained after cessation of the study. By December 2007 the blind will be broken and the data analyzed.

TRIAL REGISTRATION NUMBER

NTR: 1232.

摘要

背景

绝经后女性由于女性性激素水平降低导致肌肉力量和肌肉量减少，容易出现功能障碍。虽然激素替代疗法可能抵消这些变化，但传统激素替代疗法存在潜在有害影响，如乳腺癌风险增加，因此不建议使用。出于这个原因，新型替代药物，如具有雌激素、孕激素和雄激素活性的合成类固醇替勃龙，以及选择性雌激素受体调节剂雷洛昔芬，可能更为合适。本试验研究替勃龙和雷洛昔芬对肌肉力量的影响。

方法

在我们的单中心随机、双盲、双模拟、安慰剂对照试验中，招募了318名老年女性。参与者被随机分为每日服用替勃龙1.25毫克（荷兰欧加农公司的Org OD 14）加安慰剂、雷洛昔芬60毫克（美国礼来公司的易维特）加安慰剂或两片安慰剂，为期24个月。主要目的是确定替勃龙与安慰剂之间是否存在差异，或者雷洛昔芬与安慰剂之间是否存在差异。主要终点是肌肉力量和骨矿物质密度。次要终点是姿势平衡、身体成分、认知功能、焦虑、情绪和生活质量。次要目的是确定替勃龙与雷洛昔芬之间是否存在差异。效应的衡量指标是从基线访视到3个月、6个月、12个月和24个月后访视的变化。计划在30个月时进行随访测量，以确定研究停止后任何效应是否持续。到2007年12月将揭盲并分析数据。