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

• 批准号: 8627711
• 负责人: JERI WANZOR NIEVES
• 金额: $ 30.58万
• 依托单位: HELEN HAYES HOSPITAL
• 依托单位国家: 美国
• 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
• 来源: https://reporter.nih.gov/project-details/8627711
• 关键词: Acute; Address; Age; Age-Years; Aging; Bed rest; Blinded; Budgets; Caring; Case Report Form; Clinical; Clinical Trials; Comorbidity; Data; Data Collection; Development; Direct Costs; Dose; Double-Blind Method; Elderly; Eligibility Determination; Evaluation; Facilities and Administrative Costs; Forteo; Fracture; Fracture Healing; Future; Goals; Grant; Healed; Healthcare; Hip Fractures; Hospitals; Incidence; Injection of therapeutic agent; Institution; Institutional Review Boards; Laboratories; Lead; Length of Stay; Lower Extremity; Manuals; Medical; Methods; Narcotics; Nurse Practitioners; Operative Surgical Procedures; Osteoporosis; Pain; Pain management; Patients; Pelvis; Performance; Pharmaceutical Preparations; Physical Function; Placebos; Population; Prevention; Procedures; Protocols documentation; Radiation; Randomized; Randomized Controlled Trials; Research; Resources; Safety; Techniques; Teriparatide; Training Activity; Trauma; Visit; Visual; Woman; analog; base; chronic pain; clinical care; cost; data management; effective therapy; falls; follow-up; functional outcomes; healing; human old age (65+); improved; loss of function; mortality; novel; operation; parathyroid hormone (1-34); patient population; placebo controlled study; public health relevance; randomized placebo controlled trial; standard care; standing height; subcutaneous; time use; treatment strategy; volunteer; willingness

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，患者每年92/100,000年[1] [1]，患者每年446/100,000> 85岁[2]。女性的骨盆骨折率较高[3]，> 60岁的患者的骨盆骨折的94％被定义为与骨质疏松相关的骨折[1]。对于这项拟议的随机安慰剂对照研究，骨盆骨折是最常见，相关且实用的。这种断裂伴随着剧烈的疼痛，慢性固定性以及老年人的功能和独立性丧失[4]。骨盆骨折的当前治疗策略包括疼痛管理，患者动员以及预防与合并症相关的并发症。这些断裂可以消耗大量的医疗保健资源，并通过对行政索赔数据的分析，是与骨质疏松相关的最昂贵的骨折之一[6]。随着人群的老龄化，预期的骨盆骨折发病率也随之增加，迫切需要寻找可以加速愈合的有效治疗方法。 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.在为期一年的计划期内，我们将评估该患者人群启动治疗和参与计划试验的可行性的意愿。最终协议，操作和安全计划手册以及IRB批准将完成。对于这项拟议的随机双盲安慰剂对照研究，耻骨杆的断裂是最相关和实用的，因为这种骨折伴随着严重的疼痛和老年人的痛苦，与延迟的骨折愈合有关，几乎总是非手术性治疗。可用于加速骨折愈合的成功辅助疗法的发展将导致改善护理和减少骨盆骨折的成本。我们假设开发成功的辅助疗法以加速骨折愈合将导致改善护理，并降低骨盆骨折的直接和间接成本。在我们未来的急性骨盆骨折患者中的随机，盲试验中，我们将在3个月的治疗中解决3个特定目标：1。确定TPTD与安慰剂（具有标准护理）是否会导致早期证据表明在常规X光片上进行皮质桥梁，并在常规射线照相上进行了确认性重点CT，然后是一种新型的低辐射曝光CT技术。 2.确定TPTD与安慰剂（具有标准护理）是否导致疼痛的速度更快减轻，这是通过视觉模拟量表和使用毒素使用减少所评估的。 3。确定TPTD与安慰剂（具有标准护理）是否会更快地导致使用短的身体性能电池来改善功能结果来评估下肢功能。