Fracture Recovery for Returning to Duty (Teriparatide STRONG)

NCT ID: NCT04589819

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2026-12-30

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.

Conditions

Stress Fracture of Tibia or Fibula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Teriparatide

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.

Group Type: ACTIVE_COMPARATOR

Teriparatide

Intervention Type: DRUG

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.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Other Intervention Names

Forteo; Placebo

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Eisenhower Army Medical Center

FED

Sponsor Role: collaborator

Moncrief Army Health Clinic

UNKNOWN

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

J. Benjamin Jackson III, MD, MBA

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James B Jackson, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina School of Medicine

Locations

Fort Jackson

Columbia, South Carolina, United States

Countries

United States

Other Identifiers

19-08190

Identifier Type: -

Identifier Source: org_study_id

NCT04533984

Identifier Type: -

Identifier Source: nct_alias