Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Launched by UNIVERSITY OF SOUTH CAROLINA · Aug 26, 2020
Trial Information
Current as of May 01, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The Fracture Recovery for Returning to Duty trial is studying whether a medication called FORTEO (teriparatide) can help speed up the healing of stress fractures in soldiers undergoing basic training. Stress fractures are small cracks in the bone that can occur from repetitive activity, which is common in military training. This study will involve soldiers at Fort Jackson, South Carolina, and will compare the effects of teriparatide against a placebo (a substance with no active medication) to see if it helps them recover faster and get back to their training.
To participate in this trial, soldiers must be at least 18 years old, currently in basic training at Fort Jackson, and diagnosed with a specific type of stress fracture in their tibia (the shin bone). They will need to be willing to take the study medication and commit to the study for up to a year. However, those with certain medical conditions, such as cancer or recent kidney stones, cannot participate. If eligible, participants can expect to receive the medication or placebo through self-injection and will be monitored throughout the study to assess their recovery progress. This research could provide valuable information on improving fracture healing for active-duty soldiers.
Gender
All
Eligibility criteria
- Inclusion Criteria:
- • Soldiers actively enlisted in the US Army attached to basic training unit at Fort Jackson who are 18 years of age or older.
- • Soldiers diagnosed with a diaphyseal tibial stress fracture
- • Skeletally mature
- • Willing to self-administer study medication
- • Desire to continue their military commitment and are willing to participate for the length of the project for up to one year.
- 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 participants 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
- • Elevated uric acid
- • Orthostatic hypotension
About University Of South Carolina
The University of South Carolina (USC) is a leading research institution dedicated to advancing healthcare through innovative clinical trials and studies. With a commitment to excellence in research and education, USC leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical investigations aimed at improving patient outcomes and addressing pressing health challenges. Collaborating with a diverse network of healthcare professionals, researchers, and community partners, USC fosters an environment of discovery and translation, ensuring that findings from clinical trials contribute significantly to the advancement of medical science and evidence-based practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbia, South Carolina, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Spans from time of enrollment until return to full-duty. This could range from 12 weeks to 24 weeks
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