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Parathyroid Hormone Analog

Forteo for Fracture Healing

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

Soldiers actively enlisted in the US Army attached to basic training unit at Fort Jackson who are 18 years of age or older.

Willing to self-administer study medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow-up films will be obtained in post-enrollment weeks 4, 12, 16, and 48

Awards & highlights

Study Summary

This trial will test whether the drug FORTEO can help heal stress fractures and reduce recovery time for people in the US Army.

Who is the study for?

This trial is for US Army soldiers at Fort Jackson, aged 18 or older with a specific type of leg bone stress fracture. Participants must be willing to self-administer medication and commit to the study for up to a year. Excluded are those with prior radiation therapy on bones, pregnancy, certain bone diseases, recent kidney stones, high calcium or uric acid levels, low blood pressure upon standing, or any cancer history.Check my eligibility

What is being tested?

The study tests FORTEO (teriparatide), an injectable drug used in osteoporosis patients but here aimed at speeding up bone healing in soldiers with leg fractures. It's a controlled test where some get FORTEO and others get a placebo without knowing which one they receive.See study design

What are the potential side effects?

Possible side effects of FORTEO include nausea, dizziness when getting up too fast due to low blood pressure (orthostatic hypotension), increased risk of kidney stones if there's already a tendency towards them, and elevated calcium levels.

Eligibility Criteria

Inclusion Criteria

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

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I am an active US Army soldier, 18 or older, stationed at Fort Jackson.

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I am willing to take the study medication by myself.

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I am a soldier with a diagnosed stress fracture in the shaft of my tibia.

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My bones have stopped growing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow-up films will be obtained in post-enrollment weeks 4, 12, 16, and 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow-up films will be obtained in post-enrollment weeks 4, 12, 16, and 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up films will be obtained in post-enrollment weeks 4, 12, 16, and 48 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Days from diagnosis to full return to duty

Secondary outcome measures

Change from baseline in Tibial A-P and Lateral Radiographic Findings

Dual-Energy X-Ray Absorptiometry

Change in Non-Contrast Tibial Magnetic Resonance Imaging Findings

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention with 28-day self-injection of ForteoExperimental Treatment1 Intervention

The active study medication FORTEO is recombinant human parathyroid hormone analog, [rhPTH]. The study medication Forteo (teriparatide [rDNA origin] injection) (Eli-Lilly, Indiana, USA), will be self-administered via a blinded injection pen in the abdominal wall or thigh as described in the product guide. Subjects in the teriparatide arm will receive a 20 mcg dose of the medication daily for 28 days. Following this period the participant will receive standard physical therapy until full-return to duty.

Group II: Placebo with 28-day self injection of inactive substancePlacebo Group1 Intervention

Participants will self-administered a placebo substance normal in a replica, blinded, injection pen via in the abdominal wall or thigh daily for 28 days. Following this period the participant will receive standard physical therapy until full-return to duty.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of South CarolinaLead Sponsor

211 Previous Clinical Trials

120,276 Total Patients Enrolled

Washington University School of MedicineOTHER

1,931 Previous Clinical Trials

2,299,526 Total Patients Enrolled

James B Jackson, MDPrincipal InvestigatorPrincipal Investigator

1 Previous Clinical Trials

183 Total Patients Enrolled

Media Library

Forteo Injectable Product (Parathyroid Hormone Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04533984 — Phase 4

Fracture Healing Research Study Groups: Placebo with 28-day self injection of inactive substance, Intervention with 28-day self-injection of Forteo

Fracture Healing Clinical Trial 2023: Forteo Injectable Product Highlights & Side Effects. Trial Name: NCT04533984 — Phase 4

Forteo Injectable Product (Parathyroid Hormone Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04533984 — Phase 4

Frequently Asked Questions

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

Are there opportunities for individuals to participate in this clinical investigation?

"Evidently, this medical research is not currently recruiting participants. It was initially posted on October 1 2020 and the most recent update occurred September 1st of that same year. However, there are 430 other trials actively looking for volunteers at present."

Answered by AI

What data has been gathered from previous experiments using Forteo Injectable Product?

"Presently, there exist 59 trials exploring the effects of Forteo Injectable Product. Of those active clinical experiments, 17 are in Phase 3. Though most trial sites for this treatment lie within Columbia, South carolina, 6491 locations across the world host studies related to it."

Answered by AI

Do I meet the necessary criteria to partake in this experiment?

"This research seeks 183 participants, aged 18-40, with fracture healing willing to commit their service in the US Army for up to 12 months. Candidates must be physically mature and assigned to a basic training unit at Fort Jackson."

Answered by AI

Is the age of eligibility for this research experiment restricted to those over 25?

"This clinical trial is accepting potential participants who are legally of age and below 40."

Answered by AI

In what cases is Forteo Injectable Product commonly prescribed?

"Forteo Injectable Product has demonstrated effectiveness in treating anticonvulsants, kidney failure, and joint conditions."

Answered by AI

How many participants are being incorporated into this research study?

"Unfortunately, this clinical trial is not in the process of recruiting at this time. It was initially posted on October 1st 2020 and its last update occured September 1st 2020. However, if you are searching for additional studies there are 371 medical trials related to fracture healing and 59 research projects involving Forteo Injectable Product that require participants."

Answered by AI