Fracture Recovery for Returning to Duty (Teriparatide STRONG)

Status

Enrolling by invitation

Phase

Phase 4

Enrollment

183 participants (estimated)

Sponsor

University of South Carolina · Other

Design

Randomized · Quadruple masking

Countries

1 country

United States

Start

8 Dec 2022

Primary completion

30 Dec 2026 (estimated)

Completion

30 Dec 2026 (estimated)

First posted

19 Oct 2020

Last update posted

13 Feb 2023

Conditions

Stress Fracture of Tibia or Fibula

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.

• 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.

• 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.

1. Time from diagnosis to full return to activity

   Time frame · 3 years

   Registry description

   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.

2. Evaluation of long-term effects of the administration of teriparatide

   Time frame · 3 years

   Registry description

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

   Time frame · 3 years

   Registry description

   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.

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

   Time frame · 3 years

   Registry description

   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.

No study cites this trial.