Fracture Recovery for Returning to Duty (Teriparatide STRONG)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Teriparatide, Placebos.
- Who it may be relevant to
- Registry conditions: Stress Fracture of Tibia or Fibula. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Drug Teriparatide
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. - Drug Placebos
Placebo will be a sugar solution of the manufacturer's design.
Primary outcome measures
- Time from diagnosis to full return to activity [Time frame: 3 years]
- Evaluation of long-term effects of the administration of teriparatide [Time frame: 3 years]
- Evaluation of long-term effects of the administration of teriparatide on injury recurrence [Time frame: 3 years]
- Evaluation of long-term effects of the administration of teriparatide on recurrent bone stress injury [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Fort Jackson — Columbia
Identifiers
NCT: NCT04589819 · 19-08190