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Fracture Recovery for Returning to Duty (Teriparatide STRONG)

NCT04589819 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2023-02-13

No results posted yet for this study

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

Interventions

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.

DRUG

Placebos

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Eisenhower Army Medical Center

    collaborator FED

  • Moncrief Army Health Clinic

    collaborator UNKNOWN

  • University of South Carolina

    lead OTHER

Principal Investigators

  • James B Jackson, MD · University of South Carolina School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04589819 on ClinicalTrials.gov