Teriparatide for Stress Fractures

Recruiting in Palo Alto (17 mi)

Overseen by James B Jackson, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of South Carolina

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial aims to help U.S. Soldiers with tibial stress fractures heal faster using Teriparatide, a medication that builds bone mass. The goal is to reduce downtime and prevent long-term issues by speeding up bone healing. Teriparatide is a medication originally approved for treating osteoporosis by stimulating bone formation and has shown promise in accelerating fracture healing.

Eligibility Criteria

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.

Inclusion Criteria

Soldiers actively enlisted in the U.S. Army attached to basic training unit at Fort Jackson

My bones have stopped growing.

I am willing to take my own study medication.

Exclusion Criteria

I have Paget's disease of bone.

Currently pregnant

Elevated serum calcium, alkaline phosphatase or uric acid

Participant Groups

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.

Group I: Teriparatide Active Control 1 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: Placebo Placebo Group 1 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.

Teriparatide is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Forteo for:

• Osteoporosis in postmenopausal women who are at high risk for fracture
• Osteoporosis in men who are at high risk for fracture

🇪🇺 Approved in European Union as Forsteo for:

• Treatment of osteoporosis in postmenopausal women
• Treatment of osteoporosis in men at increased risk of fracture

🇨🇦 Approved in Canada as Forteo for:

• Treatment of osteoporosis in postmenopausal women who are at high risk for fracture
• Treatment of osteoporosis in men who are at high risk for fracture

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Fort Jackson Columbia, SC

Who Is Running the Clinical Trial?

University of South Carolina Lead Sponsor

United States Department of Defense Collaborator

Eisenhower Army Medical Center Collaborator

Moncrief Army Health Clinic Collaborator

References