Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial

特立帕肽 德诺苏马布 医学 绝经后骨质疏松症 骨矿物 骨质疏松症 绝经后妇女 随机对照试验 内科学 肿瘤科
作者
Joy N. Tsai,Hang Lee,Natalie L. David,Richard Eastell,Benjamin Z. Leder
出处
期刊:The Lancet Diabetes & Endocrinology [Elsevier BV]
卷期号:7 (10): 767-775 被引量:60
标识
DOI:10.1016/s2213-8587(19)30255-4
摘要

In the Denosumab and Teriparatide Administration (DATA) study, we showed that denosumab fully inhibits teriparatide-induced bone resorption while allowing for continued teriparatide-induced bone formation, resulting in larger increases in hip and spine bone mineral density (BMD) than with either drug alone. We aimed to assess whether administration of denosumab with high dose teriparatide would stimulate larger increases in bone mass than those observed in the DATA study.DATA-HD was an open-label, randomised, controlled phase 4 trial done at Massachusetts General Hospital. Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis. Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months. At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 months. Areal BMD (aBMD) was measured at 0, 3, 9, and 15 months. Treatment was given open label, but outcome assessors were masked. The primary endpoint was percentage change from baseline in spine areal BMD (aBMD) at 15 months. Women who completed at least one study visit after baseline were included in the modified intention-to-treat analysis. Safety was assessed in all randomly assigned participants. This study is registered with ClinicalTrials.gov, number NCT02176382.Between Oct 15, 2014, and June 10, 2016, 269 women were assessed for eligibility. 76 participants were randomly assigned to 20 μg teriparatide (n=39) or 40 μg teriparatide (n=37), of whom 69 completed at least one post-baseline visit. At 15 months, mean spine aBMD had increased to a significantly greater extent in the 40 μg group (17·5% [SD 6·0] increase) than the 20 μg group (9·5% [3·2]; difference 8·1%, 95% CI 5·5 to 10·6, p<0·0001). Mean femoral neck aBMD had also increased to a greater extent in the 40 μg group (6·8% [SD 4·1] increase) than the 20 μg group (4·3% [3·7]; difference 2·5%, 0·5 to 4·5, p=0·04), as did mean total hip aBMD (40 μg group, 6·1% [3·4] increase; 20 μg group, 3·9% [2·9] increase; difference 2·2%, 0·6 to 3·8, p<0·0001). 30 (77%) of 39 participants in the 20 μg group and 29 (78%) of 37 participants in the 40 μg group had an adverse event, and seven (18%) and two (5%) patients had serious adverse events. The most frequent adverse events were joint pain (15 [38%]), muscle cramp (15 [38%]), and fatigue (12 [31%]) in the 20 μg group group and fatigue (14 [38%]), nausea (16 [43%]), and joint pain (17 [46%]) in the 40 μg group. No deaths were reported.Combined treatment with teriparatide 40 μg and denosumab increases spine and hip BMD more than standard combination therapy. This large and rapid increase in bone mass suggest that this high dose regimen might provide a method of restoring skeletal integrity in patients with osteoporosis.National Institutes of Health and the Dart Foundation.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
2秒前
科研通AI2S应助HAG采纳,获得10
2秒前
3秒前
4秒前
glomming完成签到 ,获得积分10
5秒前
wanci应助南瓜气气采纳,获得30
7秒前
晓晓发布了新的文献求助10
7秒前
英姑应助梨理栗采纳,获得10
8秒前
东方红发布了新的文献求助10
8秒前
ah爱科研完成签到,获得积分10
9秒前
9秒前
11秒前
若梦易燃发布了新的文献求助10
11秒前
思源应助全若之采纳,获得10
11秒前
12秒前
13秒前
积极的笑柳完成签到,获得积分10
14秒前
JUNE发布了新的文献求助10
14秒前
小鱼发布了新的文献求助10
17秒前
小仙女212发布了新的文献求助10
18秒前
18秒前
可爱得喵喵叫的中华卷柏完成签到,获得积分10
19秒前
19秒前
tianmengkui完成签到,获得积分10
21秒前
轻松的万天完成签到 ,获得积分10
22秒前
x夏天完成签到 ,获得积分10
22秒前
晓晓完成签到,获得积分10
22秒前
繁荣的代秋完成签到 ,获得积分10
23秒前
马小跳完成签到,获得积分20
23秒前
24秒前
24秒前
25秒前
Infinit完成签到,获得积分10
26秒前
26秒前
29秒前
量子星尘发布了新的文献求助10
30秒前
y924758705发布了新的文献求助10
30秒前
31秒前
34秒前
瘦瘦天奇发布了新的文献求助10
34秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989069
求助须知:如何正确求助?哪些是违规求助? 3531351
关于积分的说明 11253589
捐赠科研通 3269939
什么是DOI,文献DOI怎么找? 1804851
邀请新用户注册赠送积分活动 882074
科研通“疑难数据库(出版商)”最低求助积分说明 809073