Fracture Recovery for Returning to Duty (Teriparatide STRONG)

• Status: Not yet recruiting
• Trial end date: 2024-09-25
• Target enrollment: 0
• Participant gender: All

Summary

FORTEO (teriparatide [rDNA origin]; Eli-Lilly, Indiana, USA) is an injectable synthetic recombinant human parathyroid hormone analog that is commonly used to treat people with osteoporosis. In the current investigation this drug will be tested to evaluate its efficacy to accelerate bone healing and decrease the convalescence time of US Army Basic Trainees who have sustained a diaphyseal tibial stress fracture (DTSF). Investigators from the University of South Carolina will collaborate with military personnel to perform a prospective, randomized, double-blind, placebo-controlled study at Fort Jackson, SC.

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

Details

• Lead Sponsor: University of South Carolina
• Collaborator: Washington University School of Medicine
• Treatments: Calcium; Teriparatide

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