Clinical trial NCT04589819: Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Official title: Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Stress Fracture of Tibia or Fibula
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Eisenhower Army Medical Center
name: Moncrief Army Health Clinic
First posted: 2020-10-19
Enrollment: 183
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be a 1:1 randomization into either the placebo arm or the 20mg teriparatide treatment arm. Soldiers will then receive training on how to self-administer study medication in a supervised setting. Both arms will receive 500mg of supplemental calcium to take orally, daily. They will then be released for the four week convalescent leave.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Time from diagnosis to full return to activity
timeFrame: 3 years
measure: Evaluation of long-term effects of the administration of teriparatide
timeFrame: 3 years
measure: Evaluation of long-term effects of the administration of teriparatide on injury recurrence
timeFrame: 3 years
measure: Evaluation of long-term effects of the administration of teriparatide on recurrent bone stress injury
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Fort Jackson
state: South Carolina
Study officials:
affiliation: University of South Carolina School of Medicine
name: James B Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References: