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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

Must not have

Prior external beam or implant radiation therapy involving the skeleton

Pediatric and young adult participants with open epiphyses

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

Drug Has Already Been Approved

Pivotal Trial

Approved for 5 Other Conditions

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy targeting my bones.

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I am a child or young adult with growing bones.

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I have Paget's disease of bone.

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I experience significant drops in blood pressure when standing up.

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I have had cancer in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Days from diagnosis to full return to duty

Secondary study objectives

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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 / 9Eligibility criteria met