Fracture Recovery for Returning to Duty (Teriparatide STRONG)

• ClinicalTrials.gov Identifier: NCT04589819
• Recruitment Status: Enrolling by invitation
• First Posted: October 19, 2020
• Last Update Posted: February 13, 2023
• Sponsor: University of South Carolina
• Collaborators: United States Department of Defense; Eisenhower Army Medical Center; Moncrief Army Health Clinic
• Information provided by (Responsible Party): J. Benjamin Jackson III, MD, MBA, University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stress Fracture of Tibia or Fibula	Drug: Teriparatide; Drug: Placebos	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: This will be a double-blinded study. All investigators will have access to the subjects results/outcomes, but will not know which randomization group the subject is in.
• Primary Purpose: Treatment
• Official Title: Fracture Recovery for Returning to Duty (Teriparatide STRONG)
• Actual Study Start Date: December 8, 2022
• Estimated Primary Completion Date: December 30, 2026
• Estimated Study Completion Date: December 30, 2026

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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.; Other Name: Forteo
Placebo Comparator: 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.	Drug: Placebos; Placebo will be a sugar solution of the manufacturer's design.; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Time from diagnosis to full return to activity [ Time Frame: 3 years ]
   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.
2. Evaluation of long-term effects of the administration of teriparatide [ Time Frame: 3 years ]
   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. Evaluation of long-term effects of the administration of teriparatide on injury recurrence [ Time Frame: 3 years ]
   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.
4. Evaluation of long-term effects of the administration of teriparatide on recurrent bone stress injury [ Time Frame: 3 years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, South Carolina

Fort Jackson

Columbia, South Carolina, United States, 29207

Sponsors and Collaborators

University of South Carolina

United States Department of Defense

Eisenhower Army Medical Center

Moncrief Army Health Clinic

Investigators

• Principal Investigator: James B Jackson, MD; University of South Carolina School of Medicine

More Information

• Responsible Party: J. Benjamin Jackson III, MD, MBA, Clinical Assistant Professor, University of South Carolina
• ClinicalTrials.gov Identifier: NCT04589819
• Obsolete Identifiers: NCT04533984
• Other Study ID Numbers: 19-08190
• First Posted: October 19, 2020
• Last Update Posted: February 13, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The case records from this study will be available for review by members of the Institutional Review Board (IRB) at Eisenhower Army Medical Center, Fort Gordon, GA, by representatives of the Food and Drug Administration (FDA) and other governmental agencies as part of their normal duties. This study is being conducted in conjunction with faculty in the Department of Orthopedics, School of Medicine, and the Department of Exercise Science, Arnold School of Public Health at the University of South Carolina, who will also have access to the testing outcomes. All records will be kept in a confidential form. Otherwise, only the Physical Therapists and Physicians conducting this study will have access to the records from this study.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Fractures, Bone; Fractures, Stress; Tibial Fractures; Wounds and Injuries; Leg Injuries; Teriparatide; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents