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

描述（由申请人提供）：骨盆骨折的发生率随着年龄的增长而增加，>患者60岁[1]为92/10万/年，>患者85岁[1]为446/10万/年。女性[3]骨盆骨折发生率较高，60岁患者>中94%的骨盆骨折被定义为骨质疏松相关骨折[1]。骨盆骨折是本随机安慰剂对照研究中最常见、最相关、最实用的。这种骨折伴随着严重的疼痛、慢性不活动、功能和独立性的丧失。目前骨盆骨折的治疗策略包括疼痛管理、患者活动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，它们是最昂贵的骨质疏松相关骨折之一。随着人口的老龄化，骨盆骨折的发生率预计会随之增加，迫切需要找到有效的治疗方法来加速愈合。这项U34研究的目标是为一项临床试验做准备，我们计划在bb0 ~ 65岁的急性骨质疏松相关骨盆骨折患者中评估每日皮下ttptd 20微克/天联合标准治疗（疼痛管理、卧床休息和预防合共病并发症）与安慰剂注射和标准治疗相比，是否能有效促进骨折愈合。在为期一年的计划期内，我们将评估该患者群体启动治疗的意愿和参与计划试验的可行性。最终方案、操作手册和安全计划以及IRB批准将完成。耻骨支骨折在这项随机双盲安慰剂对照研究中是最相关和实用的，因为这种骨折在老年人中伴随着严重的疼痛和行动不便，与骨折愈合延迟有关，并且几乎总是非手术治疗。加速骨折愈合的辅助治疗的成功发展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疗法来加速骨折愈合，将会改善护理，减少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个月的治疗中实现3个具体目标：1。为了确定TPTD与安慰剂（标准护理）是否能在常规x线片上产生早期的皮质桥接证据，随后进行验证性焦点CT（一种新型低辐射暴露CT技术）。2.通过视觉模拟量表和减少麻醉品的使用，确定TPTD与安慰剂（标准护理）是否能更快地减轻疼痛。3. 为了确定TPTD与安慰剂（标准护理）相比是否能更快地改善功能结果，使用短时间物理性能电池评估下肢功能。

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.