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临床试验/NCT04589819
NCT04589819Enrolling By Invitation4 期

Fracture Recovery for Returning to Duty (Teriparatide STRONG)

University of South Carolina1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2022年12月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
Enrolling By Invitation
入组人数
183
试验地点
1
主要终点
Time from diagnosis to full return to activity

研究概览

简要总结

The project goals are to improve combat readiness of U.S. Soldiers and sustain the availability of the military to deploy by, 1) decreasing the number of days not physically ready for duty after diagnosis of a diaphyseal tibial stress fracture, 2) decreasing the need for a physical profile or medical discharge board after bone stress injury, and 3) decreasing the recurrence rates of bone stress injuries.

详细描述

The study will examine the utility of a novel, non-operative, anabolic bone agent in the treatment of diaphyseal tibial stress fractures (DTSF). Teriparatide has been well studied in basic science and clinical studies to conclude its positive effects on building bone mass and preventing fractures in post-menopausal women. This allowed the medication to gain it an FDA indication for treatment in these groups. The investigators seek to explore additional uses for this anabolic agent in an at risk study population that has an imbalance of bone stress and bone formation resulting in a bone stress injury (BSI).

The only prior study to examine the effect of teriparatide on fracture healing demonstrated an absolute difference in the time to heal a fracture in the treatment groups, but was under powered to detect a difference. Given these positive results members of the research team have used these findings to administer teriparatide at the 20mg dose to young adult NCAA collegiate athletes who have DTSFs and other BSIs. The promising preliminary clinical observations have led the investigators to hypothesize that teriparatide will have a positive effect on bone healing and return to duty among service members with DTSFs.

A powered, prospective, controlled randomized study design will be utilized. Study subjects are to be recruited from the basic training corps at Fort Jackson via convenience sample. Soldiers who experience pain in the mid-shaft of the tibia during basic training will be evaluated and diagnosed according to the standard of care. Based on direct discussions with physical therapists stationed at Fort Jackson this diagnosis is often made by using a combination of bone scan and plain radiographs. After diagnosis, soldiers with a DTSF present to the physical therapy department for treatment and guidance for their progression of activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

This will be a double-blinded study. All investigators will have access to the subjects results/outcomes, but will not know which randomization group the subject is in.

入排标准

性别
All
接受健康志愿者

入选标准

  • Soldiers actively enlisted in the U.S. Army attached to basic training unit at Fort Jackson
  • Soldiers diagnosed with a tibial diaphyseal BSI requiring convalescent leave
  • Skeletally mature
  • Willing to self-administer study medication
  • Desire to continue their military commitment

排除标准

  • History of any form of cancer
  • Currently pregnant
  • Paget's disease of bone
  • Unexplained elevations of alkaline phosphatase (elevations in alkaline phosphatase may signal undiagnosed Paget's disease of bone)
  • Pediatric and young adult patients with open epiphyses
  • Prior external beam or implant radiation therapy involving the skeleton
  • Recent (within the last 6 months) urolithiasis (kidney stones)
  • Elevated serum calcium, alkaline phosphatase or uric acid
  • Orthostatic hypotension

研究组 & 干预措施

Teriparatide

Active Comparator

Study participants will be randomized into either the study medication arm or a placebo arm. The study medication Forteo (teriparatide [rDNA origin] injection) (El-Lilly, Indiana, USA), will be administered via an blinded injection pen in the abdominal wall or thigh as described in the product guide. Subjects in the teriparatide arm will receive a 20mg dose of the medication daily via self-injection.

干预措施: Teriparatide (Drug)

Placebo

Placebo Comparator

The placebo will be administered in a replica, blinded, injection pen in the same fashion. The study participant will self-administer the medication after being given a teaching session on medication administration by the study nurse.

干预措施: Placebos (Drug)

结局指标

主要结局

Time from diagnosis to full return to activity

时间窗: 3 years

Time to full return to activity will be measured in days from diagnosis of a bone stress injury to obtaining a passing Army Combat Fitness Test (ACFT) score.

Evaluation of long-term effects of the administration of teriparatide on injury recurrence

时间窗: 3 years

The investigators will evaluate the long-term effects of the administration of teriparatide by following the study enrollees for a 1-year period after the completion of the study drug. The team will determine the incidence of injury recurrence as defined by lost duty time.

Evaluation of long-term effects of the administration of teriparatide

时间窗: 3 years

The investigators will evaluate the long-term effects of the administration of teriparatide by following the study enrollees for a 1-year period after the completion of the study drug. The team will determine the incidence of drug related side effects. This data will be based on study nurse records during drug administration and from their data contained in the participants' Electronic Medical Records.

Evaluation of long-term effects of the administration of teriparatide on recurrent bone stress injury

时间窗: 3 years

The investigators will evaluate the long-term effects of the administration of teriparatide by following the study enrollees for a 1-year period after the completion of the study drug. The team will determine the incidence of additional or recurrent bone stress injury. This will be defined as a diagnosed bone stress injury by a physician, advanced practice provider or PCM (primary care manager) utilizing radiographic studies including: plain radiograph, MRI, and/or bone scan.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

J. Benjamin Jackson III, MD, MBA

Clinical Assistant Professor

University of South Carolina

研究点 (1)

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