Current partner codePEPTIDESDE
NCT04589819·Phase 4·INTERVENTIONAL

Fracture Recovery for Returning to Duty (Teriparatide STRONG)

Status

Enrolling by invitation

Phase

Phase 4

Enrollment

183

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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.

DRUG

Placebos

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

Timeline

From registration to results.

  1. First posted

    Oct 19, 2020

  2. Study start

    Dec 8, 2022

  3. Primary completion

    Dec 30, 2026

  4. Study completion

    Dec 30, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Feb 13, 2023

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Fort Jackson

Columbia, South Carolina, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Teriparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.