Planning for PTH(1-34) and Pelvic Fracture Healing - Randomized Controlled Trial

PTH(1-34) 和骨盆骨折愈合规划 - 随机对照试验

基本信息

  • 批准号:
    8627711
  • 负责人:
  • 金额:
    $ 30.58万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2014
  • 资助国家:
    美国
  • 起止时间:
    2014-07-01 至 2016-06-30
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): The incidence of pelvic fractures increases with age, with 92/100,000 per year in patients >60 years [1] and 446/100,000 per year in patients >85 years [2]. Pelvic fracture rates are higher in women [3] and 94% of pelvic fractures in patients >60 years of age are defined as osteoporosis-related fractures [1]. Pelvic fractures are the most common, relevant, and practical for this proposed randomized placebo controlled study. This fracture is accompanied by severe pain, chronic immobility and loss of function and independence in the elderly [4]. The current treatment strategy for pelvic fractures includes pain management, patient mobilization, and the prevention of complications associated with comorbid conditions. These fractures consume substantial healthcare resources, and from analysis of administrative claims data, they are one of the most costly osteoporosis related fractures [6]. With aging of the population, and expected concomitant increase in the incidence of pelvic fractures, there is a pressing need to find effective treatments that will accelerate healing. The goal of this U34 research is to prepare for a clinical trial where we plan to evaluate in patients >65 years of age with acute osteoporosis-related pelvic fractures, whether treatment with daily subcutaneous TPTD 20 mcg/day combined with standard care (pain management, bed rest and prevention of complications from comorbid conditions), compared with placebo injections and standard care is effective in enhancing fracture healing. During the one-year planning period, we will assess the willingness of this patient population to initiate therapy and feasibility of participation in the planned trial. The final protocol, Manual of Operations and safety plan, and IRB approvals will be completed. Fracture of the pubic ramus is most relevant and practical for this proposed randomized double-blinded placebo controlled study as this fracture is accompanied by severe pain and immobility in elderly, is associated with delayed fracture healing, and is almost always treated non- operatively. The development of a successful adjunctive therapy available to accelerate fracture healing would lead to improved care and reduced costs for pelvic fractures. We hypothesize that development of a successful adjunctive therapy to accelerate fracture healing would lead to improved care and reduce both direct and indirect costs from pelvic fractures. In our future randomized, blinded trial in patient with acute pelvic fracture, we will address 3 specific aims over 3 months of treatment: 1. To determine if TPTD versus placebo (with standard care) results in earlier evidence of cortical bridging on routine radiographs followed by confirmatory Focus CT, a novel low radiation exposure CT technique. 2.To determine if TPTD versus placebo (with standard care) leads to a faster reduction in pain as assessed by both the Visual Analog Scale and a reduction in the use of narcotics. 3. To determine if TPTD versus placebo (with standard care) leads more rapidly to improved functional outcome using a short physical performance battery to assess lower extremity function.
描述(由申请人提供):骨盆骨折的发病率随着年龄的增长而增加,60岁的患者和85岁的患者每年分别为92/100,000和446/100,000。女性骨盆骨折的发生率更高[3],在60岁的患者中,94%的骨盆骨折被定义为与骨质疏松相关的骨折[1]。骨盆骨折是这项拟议的随机安慰剂对照研究中最常见、最相关和最实用的。这种骨折伴随着剧烈的疼痛、慢性不能动弹以及老年人丧失功能和独立性[4]。目前骨盆骨折的治疗策略包括疼痛管理、患者动员和预防与合并症相关的并发症。这些骨折消耗了大量的医疗资源,从行政索赔数据的分析来看,它们是与骨质疏松相关的最昂贵的骨折之一[6]。随着人口老龄化和随之而来的骨盆骨折发病率的增加,迫切需要找到有效的治疗方法来加速愈合。这项U34研究的目标是为临床试验做准备,我们计划在65岁的急性骨质疏松症相关骨盆骨折患者中评估每日皮下注射TPTD 20微克/天结合标准护理(疼痛管理、卧床休息和预防并发症)与安慰剂注射和标准护理相比在促进骨折愈合方面是否有效。在为期一年的计划期间,我们将评估这些患者群体开始治疗的意愿和参与计划试验的可行性。最终协议、操作手册和安全计划以及IRB的批准将完成。在这项拟议的随机双盲安慰剂对照研究中,耻骨升支骨折是最相关和实用的,因为这种骨折在老年人中伴随着剧烈的疼痛和静止,与骨折延迟愈合有关,并且几乎总是非手术治疗。开发一种可加速骨折愈合的成功辅助疗法将改善骨盆骨折的护理并降低成本。我们假设,开发一种成功的辅助治疗来加速骨折愈合将导致更好的护理,并降低骨盆骨折的直接和间接成本。在我们未来对急性骨盆骨折患者的随机、盲法试验中,我们将在3个月的治疗中解决3个具体目标:1.确定TPTD与安慰剂(在标准护理下)是否导致常规X线片上皮质桥接的早期证据,随后是一种新的低辐射暴露CT技术--确认性焦点CT。2.确定TPTD与安慰剂(在标准护理下)是否能更快地减少疼痛,这是通过视觉模拟评分和减少麻醉药物的使用来评估的。3.确定TPTD与安慰剂(在标准护理下)相比是否更快地改善功能结果,使用较短的身体性能电池来评估下肢功能。

项目成果

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JERI WANZOR NIEVES其他文献

JERI WANZOR NIEVES的其他文献

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{{ truncateString('JERI WANZOR NIEVES', 18)}}的其他基金

PTH (1-34) and pelvic fracture healing: A randomized controlled trial
PTH (1-34) 和骨盆骨折愈合:一项随机对照试验
  • 批准号:
    10179318
  • 财政年份:
    2019
  • 资助金额:
    $ 30.58万
  • 项目类别:
PTH (1-34) and pelvic fracture healing: A randomized controlled trial
PTH (1-34) 和骨盆骨折愈合:一项随机对照试验
  • 批准号:
    9933509
  • 财政年份:
    2019
  • 资助金额:
    $ 30.58万
  • 项目类别:
PTH (1-34) and Pelvic Fracture Healing: A Randomized Controlled Trial
PTH (1-34) 和骨盆骨折愈合:随机对照试验
  • 批准号:
    9232321
  • 财政年份:
    2017
  • 资助金额:
    $ 30.58万
  • 项目类别:
CORE--NON-INVASIVE MEASUREMENT OF BONE MINERAL
核心——骨矿物质的无创测量
  • 批准号:
    6347259
  • 财政年份:
    2000
  • 资助金额:
    $ 30.58万
  • 项目类别:
CORE--NON-INVASIVE MEASUREMENT OF BONE MINERAL
核心——骨矿物质的无创测量
  • 批准号:
    6201522
  • 财政年份:
    1999
  • 资助金额:
    $ 30.58万
  • 项目类别:
CORE--NON-INVASIVE MEASUREMENT OF BONE MINERAL
核心——骨矿物质的无创测量
  • 批准号:
    6100472
  • 财政年份:
    1998
  • 资助金额:
    $ 30.58万
  • 项目类别:
VITAMIN D SUPPLEMENTATION IN POSTMENOPAUSAL BLACK WOMEN
绝经后黑人女性补充维生素 D
  • 批准号:
    2395695
  • 财政年份:
    1997
  • 资助金额:
    $ 30.58万
  • 项目类别:
VITAMIN D SUPPLEMENTATION IN POSTMENOPAUSAL BLACK WOMEN
绝经后黑人女性补充维生素 D
  • 批准号:
    2769406
  • 财政年份:
    1997
  • 资助金额:
    $ 30.58万
  • 项目类别:
VITAMIN D SUPPLEMENTATION IN POSTMENOPAUSAL BLACK WOMEN
绝经后黑人女性补充维生素 D
  • 批准号:
    6372085
  • 财政年份:
    1997
  • 资助金额:
    $ 30.58万
  • 项目类别:
VITAMIN D SUPPLEMENTATION IN POSTMENOPAUSAL BLACK WOMEN
绝经后黑人女性补充维生素 D
  • 批准号:
    6169567
  • 财政年份:
    1997
  • 资助金额:
    $ 30.58万
  • 项目类别:

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