Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Fracture Recovery for Returning to Duty (Teriparatide STRONG)
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 injury (BSI).

 The only prior study to examine the effect of teriparatide on fracture healing demonstrated
 an absolute difference in the time to heal a fracture in the treatment groups, but was under
 powered to detect a difference. Given these positive results members of the research team
 have used these findings to administer teriparatide at the 20mg dose to young adult NCAA
 collegiate athletes who have DTSFs and other BSIs. The promising preliminary clinical
 observations have led the investigators to hypothesize that teriparatide will have a positive
 effect on bone healing and return to duty among service members with DTSFs.

 A powered, prospective, controlled randomized study design will be utilized. Study subjects
 are to be recruited from the basic training corps at Fort Jackson via convenience sample.
 Soldiers who experience pain in the mid-shaft of the tibia during basic training will be
 evaluated and diagnosed according to the standard of care. Based on direct discussions with
 physical therapists stationed at Fort Jackson this diagnosis is often made by using a
 combination of bone scan and plain radiographs. After diagnosis, soldiers with a DTSF present
 to the physical therapy department for treatment and guidance for their progression of
 activities.
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