Stress Fracture of Tibia or FibulaPhase 4NCT04589819
Fracture Recovery for Returning to Duty (Teriparatide STRONG)
A Phase 4 study testing Teriparatide in people with Stress Fracture of Tibia or Fibula, run by University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress Fracture of Tibia or Fibula
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2022to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Recent (within the last 6 months) urolithiasis (kidney stones)
- Elevated serum calcium, alkaline phosphatase or uric acid
- Orthostatic hypotension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Being tested
- Teriparatide, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo
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.
PlacebosDrug
Also called Placebo
Placebo will be a sugar solution of the manufacturer's design.
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide | Active comparator | 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. Receives: Drug: Teriparatide |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start8 Dec 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Fracture of Tibia or FibulaStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Eisenhower Army Medical Center, Moncrief Army Health Clinic
- Responsible party
- Principal investigator, J. Benjamin Jackson III, MD, MBA, University of South Carolina
- Investigators
- James B Jackson, MD, Principal investigator, University of South Carolina School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589819
- Sponsor's protocol ID
- 19-08190
- Status last verified
- Feb 2023
- First submitted
- 24 Sep 2020
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fracture Recovery for Returning to Duty (Teriparatide STRONG)
- ClinicalTrials.gov ID
- NCT04589819
- Acronym / sponsor ID
- 19-08190
- Conditions
- Stress Fracture of Tibia or Fibula
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- United States Department of Defense, Eisenhower Army Medical Center, Moncrief Army Health Clinic
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Teriparatide | Active comparator | Drug: TeriparatideStudy 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. |
| Placebo | Placebo comparator | Drug: PlacebosThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriparatideAlso: ForteoTeriparatide, 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. | Drug | Teriparatide |
| PlacebosAlso: PlaceboPlacebo will be a sugar solution of the manufacturer's design. | Drug | Placebo |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James B Jackson, MD principal investigator
University of South Carolina School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teriparatide in people with Stress Fracture of Tibia or Fibula, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from diagnosis to full return to activity (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.