University of South Carolina
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.
The study will examine the utility of a novel, non-operative, anabolic bone agent in the treatment of diaphyseal tibial stress fractures (DTSF). Teriparatide has been well studied in basic science and clinical studies to conclude its positive effects on building bone mass and preventing fractures in post-menopausal women. This allowed the medication to gain it an FDA indication for treatment in these groups. The investigators seek to explore additional uses for this anabolic agent in an at risk study population that has an imbalance of bone stress and bone formation resulting in a bone stress…
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 *…
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.
Placebo will be a sugar solution of the manufacturer's design.
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