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
• 负责人: JERI WANZOR NIEVES
• 金额: $ 45.88万
• 依托单位: HELEN HAYES HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-02-01 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9232321
• 关键词: Acute; Address; Age; Age-Years; Aging; Agreement; Bed rest; Blinded; Caring; Chronic; Clinical; Clinical Trials; Comorbidity; 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; Placebo Control; Placebos; Population; Prevalence; Prevention; Quality of Care; Radiation exposure; Randomized; Randomized Controlled Trials; Recovery of Function; Recruitment Activity; 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; 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急剧增加，从每10，000人5.4和3.8人- 65至69岁男女的平均死亡率分别为每10 000人年93.5和44.5人年 年龄分别为90岁和90岁以上。3骨盆骨折伴有剧烈疼痛、慢性不动 以及老年人功能和独立性的丧失。14骨盆骨折消耗大量的医疗保健 资源，并根据行政索赔数据，他们是最昂贵的骨质疏松症相关的 骨折未愈合，发生在三分之一的骨盆骨折患者在3个月内，16可导致 持续的疼痛和影响移动性。随着人口老龄化，以及预期随之而来的 骨盆骨折的发病率，迫切需要找到有效的治疗方法，将加速愈合。 耻骨支骨折对于随机、双盲、安慰剂对照研究最相关和最实用。 研究表明，由于这种骨折伴有严重的疼痛和老年人的不动， 骨折愈合，几乎总是非手术治疗。目前骨盆骨折的护理标准 包括疼痛管理、患者动员和预防与共病相关的并发症。 条件我们假设，开发一种成功的加速骨折愈合的连续治疗方法， 将改善护理并减少骨盆骨折的直接和间接成本。拟议 试验我们将招募年龄>65岁的患有急性骨关节炎相关骨盆骨折的女性和男性， 在安慰剂对照双盲研究中，在3个月的治疗期间解决3个特定目标，以确定 标准治疗和特立帕鲁肽20 mcg/天与安慰剂治疗骨盆骨折： 1.结果在常规X线片上发现皮质桥接的早期证据，随后进行确认性病灶CT，a 减少CT扫描辐射暴露的新方法（主要结局）。 2.通过数字评定量表评估，可更快减轻疼痛， 麻醉品（次要结局）。 3.使用短期体能测试组合评估，更快地改善功能结局 下肢功能（次要结局）。 我们将延长本研究，进行9个月的开放标签TPTD，以确定 安慰剂组和TPTD组在3个月的治疗期间是明显的，并随着时间的推移而持续，即使在 在3个月安慰剂对照干预后使用TPTD的患者。 如果TPTD可以改善骨折愈合，这项研究将对骨盆骨折患者的治疗产生影响 不适合手术的骨折患者，经常面临严重的疼痛、慢性不动和功能丧失， 老人骨盆骨折加速愈合的积极发现也将鼓励对TPTD的研究 用于治疗其他骨折。