Fracture Recovery for Returning to Duty (Teriparatide STRONG)

• Status: Not yet recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prisma Health-Midlands; University of South Carolina
• Collaborators: Eisenhower Army Medical Center; Moncrief Army Health Clinic; United States Department of Defense; University of South Carolina
• Treatments: Teriparatide

Criteria

Inclusion Criteria:

• 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

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 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