Teriparatide for Tibial Stress Fracture Recovery in Soldiers
This study, called Teriparatide STRONG, is looking at whether a medication called teriparatide can help soldiers recover faster from a specific type of bone injury called a diaphyseal tibial stress fracture (a break in the shin bone). Teriparatide is a synthetic (man-made) parathyroid hormone that has been shown to help build bone. Researchers want to see if it can reduce the time it takes for soldiers to return to duty and prevent these fractures from happening again. You might be able to join if you are an active U.S. Army soldier at Fort Jackson with this type of stress fracture, are skeletally mature, willing to inject the medication yourself, and want to continue your military service. The study will compare teriparatide to a placebo (a sugar solution). The main goals are to see how long it takes to return to full activity and to evaluate the long-term effects of teriparatide on recovery and injury recurrence over three years. The current status of this study is unclear.
- Study design
- This is a randomized, controlled study designed to enroll 183 participants. Participants will receive either teriparatide or a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for three years to evaluate long-term effects and injury recurrence.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Fracture Recovery for Returning to Duty (Teriparatide STRONG)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- James B Jackson, MD · PRINCIPAL_INVESTIGATOR · University of South Carolina School of Medicine
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Time from diagnosis to full return to activity3 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 teriparatide3 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 injury recurrence3 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 on recurrent bone stress injury3 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.