Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Stress Fracture of Tibia or Fibula
About this trial
This is an interventional treatment trial for Stress Fracture of Tibia or Fibula
Eligibility 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
Sites / Locations
- Fort Jackson
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Teriparatide
Placebo
Study participants will be randomized into either the study medication arm or a placebo arm. The study medication Forteo (teriparatide [rDNA origin] injection) (El-Lilly, Indiana, USA), will be administered via an blinded injection pen in the abdominal wall or thigh as described in the product guide. Subjects in the teriparatide arm will receive a 20mg dose of the medication daily via self-injection.
The placebo will be administered in a replica, blinded, injection pen in the same fashion. The study participant will self-administer the medication after being given a teaching session on medication administration by the study nurse.