Forteo for Fracture Healing

Recruiting in Palo Alto (17 mi)

Overseen byJames B Jackson, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of South Carolina

Prior Safety Data

Trial Summary

What is the purpose of this trial?

FORTEO (teriparatide [rDNA origin]; Eli-Lilly, Indiana, USA) is an injectable synthetic recombinant human parathyroid hormone analog that is commonly used to treat people with osteoporosis. In the current investigation this drug will be tested to evaluate its efficacy to accelerate bone healing and decrease the convalescence time of US Army Basic Trainees who have sustained a diaphyseal tibial stress fracture (DTSF). Investigators from the University of South Carolina will collaborate with military personnel to perform a prospective, randomized, double-blind, placebo-controlled study at Fort Jackson, SC.

Research Team

James B Jackson, MD

Principal Investigator

Eligibility Criteria

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.

Inclusion Criteria

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

I am willing to take the study medication by myself.

I am willing to commit to a project for up to a year while continuing my military service.

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Exclusion Criteria

I have had radiation therapy targeting my bones.

I have had kidney stones in the last 6 months.

Elevated uric acid

See 7 more

Treatment Details

Interventions

Forteo Injectable Product (Parathyroid Hormone Analog)
Placebo (Other)

Trial OverviewThe 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.

Participant Groups

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.