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.

本项目将研究特立哌酮（甲状旁腺激素的类似物）对加速 人类的骨折愈合过程Teriparazone目前以Forteo品牌销售 并且被FDA批准用于治疗骨质疏松症。 我们的假设是，teriparlitazone，凭借其能够刺激招募软骨形成和 成骨细胞，会加速骨折愈合过程。待测量的骨折部位为 骨盆这将包括前柱和后柱、上级支和下支以及 骶骨受试者年龄将超过55岁，骨折将是由于低能量创伤所致。 骨折愈合的评估将通过功能测试以及骨痂的放射学测量进行 容量、疼痛评估和自我感知功能。本研究设计为前瞻性、双盲、 安慰剂对照试验。将采用意向治疗分析进行分析。 在目标1中，我们将使用仪器化坐立测试、定时起身测试和步态速度， 在愈合过程中测量受试者的功能。我们还将对职能进行自我评估 问卷调查，以记录受试者对愈合的印象。在目标2中，我们将量化骨痂体积 并监测疼痛程度、精神状态和抑郁症的变化。 在这项试验结束时，我们将能够确定特立帕肽是否对功能， 骨盆骨折愈合的生物学或受试者健康方面。