P3: Role of PTH in enhancing fracture repair in aging (Clinical Trial)

P3：PTH 在增强老化骨折修复中的作用（临床试验）

• 批准号: 7891427
• 负责人: J. Edward PUZAS
• 金额: $ 27.75万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7891427
• 关键词: Age; Aging; Anterior; Biological; Bone callus; Caring; Cells; Clinical Trials; Evaluation; FDA approved; Forteo; Fracture; Fracture Healing; Gait; Healed; Human; Inferior; Marketing; Measurement; Measures; Molecular; Monitor; Names; Orthopedics; Osteoporosis; Pain; Parathyroid Hormones; Pelvis; Personal Satisfaction; Process; Questionnaires; Role; Self Assessment; Signal Pathway; Site; Teriparatide; Testing; Time; Translating; Trauma; analog; depression; design; dorsal column; healing; human PTH protein; impression; instrument; mental state; osteogenic; placebo controlled study; prospective; repaired; sacrum

This project will investigate the effects of teriparatide (an analog of parathyroid hormone) on accelerating the fracture healing process in humans. Teriparatide is currently marketed under the brand name Forteo and is FDA approved for the treatment of osteoporosis. Our hypothesis is that teriparatide, by virtue of its ability to stimulate recruitment of chondrogenic and osteogenic cells, will accelerate the fracture healing process. The fracture site to be measured will be the pelvis. This will include all fractures of the anterior and posterior columns, superior and inferior rami and the sacrum. Subjects will be over the age of 55 and the fracture will have been due to a low energy trauma. Evaluation of fracture healing will be by functional tests as well as radiographic measurements of callus volume, evaluation of pain and self-perceived function. The study is designed to be a prospective, doubleblind, placebo controlled trial. It will be analyzed with an intent-to-treat analysis. In Aim 1 we will use an instrumented sit-to-stand test, a timed-up-and-go test and gait velocity to measure subject function during healing. We will also administer a self-assessment of function questionnaire to document the subjects impression of the healing. In Aim 2 we will quantify callus volume and monitor changes in pain levels, mental status and depression. At the conclusion of this trial we will be able to determine if teriparatide has any effect on the functional, biological or subject well-being aspects of healing a pelvic fracture.

该项目将研究特立帕肽（甲状旁腺激素类似物）对加速 人类骨折愈合过程。特立帕肽目前以 Forteo 品牌销售 并获得 FDA 批准用于治疗骨质疏松症。 我们的假设是，特立帕肽能够刺激软骨生成和 成骨细胞，会加速骨折愈合过程。待测量的断裂部位将是 骨盆。这将包括前柱、后柱、上支和下支以及下支的所有骨折。 骶骨。受试者年龄超过 55 岁，骨折是由于低能量创伤造成的。 骨折愈合的评估将通过功能测试以及骨痂的放射线测量来进行 容量、疼痛评估和自我感知功能。该研究旨在成为一项前瞻性、双盲、 安慰剂对照试验。将通过意向治疗分析对其进行分析。 在目标 1 中，我们将使用仪器化的坐站测试、计时起立测试和步态速度来 测量愈合期间受试者的功能。我们还将进行功能自我评估 问卷记录受试者对治疗的印象。在目标 2 中，我们将量化愈伤组织体积 并监测疼痛程度、精神状态和抑郁的变化。 在本试验结束时，我们将能够确定特立帕肽是否对功能、功能有任何影响。 愈合骨盆骨折的生物或受试者健康方面。