Fracture Recovery for Returning to Duty (Teriparatide STRONG)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stress Fracture of Tibia or Fibula
• Intervention / Treatment: Drug: Teriparatide; Drug: Placebos

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 183
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29207
      • Fort Jackson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Teriparatide; 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.	Drug: Teriparatide; Teriparatide, an injectable synthetic parathyroid hormone, will be tested to evaluate its efficacy for decreasing the convalescence after a diaphyseal tibial stress fracture, a specific bone stress injury.; Other Names: Forteo
PLACEBO_COMPARATOR: Placebo; 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.	Drug: Placebos; Placebo will be a sugar solution of the manufacturer's design.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from diagnosis to full return to activity	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.	3 years
Evaluation of long-term effects of the administration of teriparatide	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.	3 years
Evaluation of long-term effects of the administration of teriparatide on injury recurrence	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.	3 years
Evaluation of long-term effects of the administration of teriparatide on recurrent bone stress injury	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.	3 years

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: United States Department of Defense; Eisenhower Army Medical Center; Moncrief Army Health Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2022
• Primary Completion (ANTICIPATED): December 30, 2026
• Study Completion (ANTICIPATED): December 30, 2026

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures; Fractures, Stress; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide
• Other Study ID Numbers: 19-08190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The case records from this study will be available for review by members of the Institutional Review Board (IRB) at Eisenhower Army Medical Center, Fort Gordon, GA, by representatives of the Food and Drug Administration (FDA) and other governmental agencies as part of their normal duties. This study is being conducted in conjunction with faculty in the Department of Orthopedics, School of Medicine, and the Department of Exercise Science, Arnold School of Public Health at the University of South Carolina, who will also have access to the testing outcomes. All records will be kept in a confidential form. Otherwise, only the Physical Therapists and Physicians conducting this study will have access to the records from this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes