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
• 负责人: JERI WANZOR NIEVES
• 金额: $ 56.07万
• 依托单位: HOSPITAL FOR SPECIAL SURGERY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-23 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9933509
• 关键词: Acute; Address; Age; Age-Years; Aging; Agreement; Bed rest; Blinded; Caring; Chronic; Clinical; Clinical Trials; Comorbidity; Consumption; Controlled Clinical Trials; Data; Development; Diagnostic radiologic examination; Direct Costs; Double-Blind Method; Elderly; Enrollment; Face; Facilities and Administrative Costs; Finland; Forteo; Fracture; Fracture Healing; Germany; Healthcare; Incidence; Intervention; Knowledge; Lead; Length of Stay; Lower Extremity; Measures; Methods; Narcotics; Numeric Rating Scale; Operative Surgical Procedures; Osteoporosis; Outcome; PTH gene; Pain; Pain Measurement; Pain management; Patients; Persons; Pharmaceutical Preparations; Physical Function; Physical Performance; Physical activity; Placebos; Population; Prevalence; Prevention; Quality of Care; Radiation exposure; Randomized; Randomized Controlled Trials; Recovery of Function; Resources; Speed; Time; Trauma; Woman; X-Ray Computed Tomography; aged; base; bone; chronic pain; clinical practice; cost; effective therapy; falls; follow-up; functional outcomes; healing; improved; loss of function; men; mortality; novel; open label; osteoporosis with pathological fracture; parathyroid hormone (1-34); pelvis fracture; peptide hormone; placebo controlled study; pre-clinical; primary outcome; randomized placebo controlled trial; recruit; repaired; sample fixation; secondary outcome; standard care; standard of care; standing height; subcutaneous; treatment strategy; wrist fracture

Technical Abstract The incidence rate of pelvic fractures increases dramatically with age, from 5.4 and 3.8 per 10,000 person- years in women and men aged 65 to 69 years to 93.5 and 44.5 per 10,000 person-years in women and men aged 90 years and older, respectively.3 Pelvic fractures are accompanied by severe pain, chronic immobility and loss of function and independence in the elderly.14 Pelvic fractures consume substantial healthcare resources, and based on administrative claims data, they are one of the most costly osteoporosis related fractures.4 Un-healed fractures, occurring in one-third of pelvic fracture patients at 3 months,16 can cause continued pain and impact mobility. 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. Fracture of the pubic ramus is most relevant and practical for 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 current standard of care for pelvic fractures includes pain management, patient mobilization, and the prevention of complications associated with comorbid conditions. 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 the proposed trial we will recruit women and men >65 years of age with acute osteoporosis-related pelvic fractures and address 3 specific aims over 3 months of treatment in a placebo controlled double blind study to determine if standard care and teriparatide 20 mcg/day versus placebo for pelvic fractures: 1. Results in earlier evidence of cortical bridging on routine radiographs followed by confirmatory Focus CT, a novel method to reduce radiation exposure from CT scans (primary outcome). 2. Leads to a faster reduction in pain as assessed by both the Numeric Rating Scale and a reduction in the use of narcotics (secondary outcome). 3. Leads more rapidly to improved functional outcome using a short physical performance battery to assess lower extremity function (secondary outcome). We will extend this study with 9 months of open label TPTD to determine if any potential differences between the placebo and TPTD groups during the 3 months of treatment are evident and persist over time, even in patients who use TPTD after the three month placebo controlled intervention. If TPTD can improve fracture healing, this study will have an impact on the treatment of persons with pelvic fracture who are not surgical candidates and often face severe pain, chronic immobility, and loss of function in the elderly. A positive finding of accelerated healing of pelvic fractures would also encourage study of TPTD for treatment of other osteoporotic fractures.

技术摘要 骨盆骨折的发病率随着年龄的增长而大大增加，从每10,000人中的5.4和3.8 年龄在65至69岁至93.5岁的男性和男性的年龄和男性年满44.5岁 分别为90岁以上。3骨盆骨折伴有严重的疼痛，慢性不动 老年人的功能和独立性丧失。14骨盆骨折消耗大量医疗保健 资源和基于行政索赔数据，它们是与骨质疏松相关的最昂贵的 裂缝。4未裂伤的裂缝，发生在三分之一的骨盆骨折患者3个月中，16例可能导致16例 持续的疼痛和影响流动性。随着人口的老龄化，并期望同时增加 骨盆骨折的发病率是迫切需要寻找可以加速愈合的有效治疗方法。 耻骨的断裂对于随机双盲安慰剂控制最相关，最实用 研究由于这种骨折伴随着严重的疼痛和老年人的固定性，与延迟有关 断裂愈合，几乎总是被非手术治疗。骨盆骨折的当前护理标准 包括疼痛管理，患者动员以及预防与合并症相关的并发症 状况。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，并减少骨盆骨折的直接和间接成本。在提议中 试验我们将招募与急性骨质疏松相关的骨盆骨折和男性> 65岁的男性 在安慰剂受控的双盲研究中，在3个月的治疗中解决3个具体目标，以确定是否是否 标准护理和Teriparatide 20 mcg/天与安慰剂的骨盆骨折： 1。导致较早的证据表明在常规X光片上进行皮质桥接，然后进行确认焦点CT，A 减少CT扫描辐射暴露的新方法（主要结果）。 2。导致疼痛的减轻速度，如数字评级量表和使用降低所评估 麻醉品（次要结果）。 3。使用短体性能电池更快地提高功能结果来评估 下肢功能（次要结果）。 我们将使用9个月的开放标签TPTD扩展这项研究，以确定是否有潜在的差异 安慰剂和TPTD组在三个月的治疗中是显而易见的，并且随着时间的流逝，即使在 安慰剂控制干预后三个月后使用TPTD的患者。 如果TPTD可以改善断裂愈合，这项研究将对骨盆患者的治疗产生影响 不是手术候选者，并且经常面临严重疼痛，慢性固定和功能丧失的断裂 老人。骨盆骨折加速愈合的积极发现也将鼓励研究TPTD 用于治疗其他骨质疏松性骨折。