Fracture Recovery for Returning to Duty (Teriparatide STRONG)

NCT04589819 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: 19-08190
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Fracture of Tibia or Fibula

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Drug: Teriparatide

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.

Drug: Placebos

Interventions

Teriparatide DRUG

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.

Also known as: Forteo

Teriparatide

Placebos DRUG

Placebo will be a sugar solution of the manufacturer's design.

Also known as: Placebo

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• United States Department of Defense: collaborator
• Eisenhower Army Medical Center: collaborator
• Moncrief Army Health Clinic: collaborator

Study Sites (1)

Fort Jackson

Columbia, South Carolina, 29207, United States

Location

MeSH Terms

Interventions

Teriparatide

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• James B Jackson, MD

  University of South Carolina School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: There will be a 1:1 randomization into either the placebo arm or the 20mg teriparatide treatment arm. Soldiers will then receive training on how to self-administer study medication in a supervised setting. Both arms will receive 500mg of supplemental calcium to take orally, daily. They will then be released for the four week convalescent leave.

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 19, 2020
• Study Start: December 8, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)