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Fracture Recovery for Returning to Duty (Teriparatide STRONG)

Primary Purpose

Stress Fracture of Tibia or Fibula

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Teriparatide
Placebos
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Fracture of Tibia or Fibula

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fort Jackson

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Teriparatide

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2020
Last Updated
February 9, 2023
Sponsor
University of South Carolina
Collaborators
United States Department of Defense, Eisenhower Army Medical Center, Moncrief Army Health Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04589819
Brief Title
Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Official Title
Fracture Recovery for Returning to Duty (Teriparatide STRONG)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
United States Department of Defense, Eisenhower Army Medical Center, Moncrief Army Health Clinic

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Fracture of Tibia or Fibula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
183 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teriparatide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
Forteo
Intervention Description
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
Intervention Name(s)
Placebos
Other Intervention Name(s)
Placebo
Intervention Description
Placebo will be a sugar solution of the manufacturer's design.
Primary Outcome Measure Information:
Title
Time from diagnosis to full return to activity
Description
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.
Time Frame
3 years
Title
Evaluation of long-term effects of the administration of teriparatide
Description
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.
Time Frame
3 years
Title
Evaluation of long-term effects of the administration of teriparatide on injury recurrence
Description
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.
Time Frame
3 years
Title
Evaluation of long-term effects of the administration of teriparatide on recurrent bone stress injury
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B Jackson, MD
Organizational Affiliation
University of South Carolina School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fort Jackson
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Fracture Recovery for Returning to Duty (Teriparatide STRONG)

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