Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Stress Fracture, Fracture Healing, Military Training
About this trial
This is an interventional treatment trial for Stress Fracture focused on measuring Military Training, Stress Fracture, Osteoanabolic, Rehabilitation
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
Sites / Locations
- Fort Jackson, SC
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intervention with 28-day self-injection of Forteo
Placebo with 28-day self injection of inactive substance
The active study medication FORTEO is recombinant human parathyroid hormone analog, [rhPTH]. The study medication Forteo (teriparatide [rDNA origin] injection) (Eli-Lilly, Indiana, USA), will be self-administered via a blinded injection pen in the abdominal wall or thigh as described in the product guide. Subjects in the teriparatide arm will receive a 20 mcg dose of the medication daily for 28 days. Following this period the participant will receive standard physical therapy until full-return to duty.
Participants will self-administered a placebo substance normal in a replica, blinded, injection pen via in the abdominal wall or thigh daily for 28 days. Following this period the participant will receive standard physical therapy until full-return to duty.