Fracture Recovery for Returning to Duty (Teriparatide STRONG)

Stress Fracture of Tibia or Fibula Clinical Trial

Official title:

Fracture Recovery for Returning to Duty (Teriparatide STRONG)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04589819
• Other study ID #: 19-08190
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: December 8, 2022
• Est. completion date: December 30, 2026

Study information

• Verified date: February 2023
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 183
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Stress
• Stress Fracture of Tibia or Fibula
• Tibial Fractures

Intervention

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.
• Placebos
Placebo will be a sugar solution of the manufacturer's design.

Locations

Country	Name	City	State
United States	Fort Jackson	Columbia	South Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of South Carolina	Eisenhower Army Medical Center, Moncrief Army Health Clinic, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from diagnosis to full return to activity	Time to full return to activity will be measured in days from diagnosis of a bone stress injury to obtaining a passing Army Combat Fitness Test (ACFT) score.	3 years
Primary	Evaluation of long-term effects of the administration of teriparatide	The investigators will evaluate the long-term effects of the administration of teriparatide by following the study enrollees for a 1-year period after the completion of the study drug. The team will determine the incidence of drug related side effects. This data will be based on study nurse records during drug administration and from their data contained in the participants' Electronic Medical Records.	3 years
Primary	Evaluation of long-term effects of the administration of teriparatide on injury recurrence	The investigators will evaluate the long-term effects of the administration of teriparatide by following the study enrollees for a 1-year period after the completion of the study drug. The team will determine the incidence of injury recurrence as defined by lost duty time.	3 years
Primary	Evaluation of long-term effects of the administration of teriparatide on recurrent bone stress injury	The investigators will evaluate the long-term effects of the administration of teriparatide by following the study enrollees for a 1-year period after the completion of the study drug. The team will determine the incidence of additional or recurrent bone stress injury. This will be defined as a diagnosed bone stress injury by a physician, advanced practice provider or PCM (primary care manager) utilizing radiographic studies including: plain radiograph, MRI, and/or bone scan.	3 years