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Osteoporosis Agent

Teriparatide for Stress Fractures

Phase 4

Waitlist Available

Led By James B Jackson, MD

Research Sponsored by University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Skeletally mature

Willing to self-administer study medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial aims to reduce U.S. military deployment delays and recurrence of bone stress injuries, to improve combat readiness.

Who is the study for?

This trial is for U.S. Army soldiers at Fort Jackson who want to continue their military service and have a diagnosed tibial stress fracture requiring time off duty. Participants must be adults willing to self-administer the study medication and not currently pregnant, without Paget's disease, recent kidney stones, cancer history, or certain blood abnormalities.Check my eligibility

What is being tested?

The trial is testing Teriparatide against a placebo in improving recovery from tibial fractures. The goal is to reduce recovery time, prevent medical discharge due to bone injuries, and lower the chances of future fractures among soldiers.See study design

What are the potential side effects?

Teriparatide may cause side effects such as nausea, dizziness (especially when getting up), leg cramps or pain at the injection site. There might also be an increased risk of developing kidney stones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bones have stopped growing.

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I am willing to take my own study medication.

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I am a soldier diagnosed with a shin bone stress injury needing time off.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluation of long-term effects of the administration of teriparatide

Evaluation of long-term effects of the administration of teriparatide on injury recurrence

Evaluation of long-term effects of the administration of teriparatide on recurrent bone stress injury

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TeriparatideActive Control1 Intervention

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 II: PlaceboPlacebo Group1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

863 Previous Clinical Trials

227,449 Total Patients Enrolled

Eisenhower Army Medical CenterFED

8 Previous Clinical Trials

2,040 Total Patients Enrolled

University of South CarolinaLead Sponsor

211 Previous Clinical Trials

120,276 Total Patients Enrolled

Media Library

Teriparatide (Osteoporosis Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04589819 — Phase 4

Stress Fracture of the Tibia or Fibula Clinical Trial 2023: Teriparatide Highlights & Side Effects. Trial Name: NCT04589819 — Phase 4

Teriparatide (Osteoporosis Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04589819 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you inform me of other research studies that have utilized Teriparatide?

"Currently, 10 active studies exploring the efficacy of teriparatide have been launched with none reaching Phase 3. Most are being conducted in Hong Kong; however, there are also 38 other locations running trials."

Answered by AI

Is the use of Teriparatide associated with any adverse effects?

"Teriparatide has already been approved for clinical use, resulting in a score of 3."

Answered by AI

Are there any vacancies for participants in this exploration?

"At present, no further participants are being sought for this clinical trial. The posting first went up on December 8th 2022 and was updated as recently as February 9th 2023. If you seek other studies to join, there are presently 375 trials recruiting those with stress fracture of the tibia or fibula and 10 Teriparatide-related studies actively seeking patients."

Answered by AI

What is the size of the study population for this experiment?

"Unfortunately, this study has concluded its recruitment process. It was initially advertised on December 8th 2022 and last updated February 9th 2023. If you're seeking other studies, there are currently 375 related to stress fracture of the tibia or fibula and 10 involving Teriparatide that are actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fracture Recovery for Returning to Duty (Teriparatide STRONG)

J. Benjamin Jackson III, MD, MBA 2022. "Fracture Recovery for Returning to Duty (Teriparatide STRONG)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04589819.

All > Forteo