权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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

基本信息

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
项目类别：
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

项目摘要

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.

技术文摘