Teriparatide for Stress Fractures

Overseen By Lorri Gibbons

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: University of South Carolina

Disqualifiers: Cancer, Pregnancy, Paget's, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called Teriparatide (also known as Forteo) to determine if it can help soldiers recover faster from stress fractures in the tibia. The goal is to reduce the time soldiers are unable to perform their duties due to these injuries and lower the chances of recurrence. Participants will self-inject either Teriparatide or a placebo (a treatment with no active medication). Soldiers diagnosed with a stress fracture in their tibia and currently on leave to recover may be suitable candidates for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Teriparatide?

Research has shown that teriparatide, the treatment being considered for stress fractures, has been safely used to aid bone healing. Administered as an injection, it is generally well-tolerated for improving bone health.

One study found that teriparatide effectively heals fractures that are slow to heal or not healing at all, without major safety concerns. However, it is more commonly associated with increased calcium levels than with fractures. This is important to consider when thinking about joining a trial.

Additionally, the FDA has already approved teriparatide for treating certain bone conditions, indicating its well-known safety profile, but it should not be used for more than two years. Always consult a healthcare provider about potential risks before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for stress fractures, which often involve rest and pain management, teriparatide offers a unique approach. Teriparatide is a synthetic form of parathyroid hormone that stimulates bone growth, potentially speeding up the healing process. This mechanism of action is distinct because it actively promotes bone formation, rather than just alleviating symptoms. Researchers are excited about teriparatide because it might significantly reduce recovery time for individuals suffering from stress fractures, offering a proactive solution rather than a passive one.

What is the effectiveness track record for Teriparatide in treating stress fractures?

Research has shown that teriparatide, which participants in this trial may receive, effectively treats stress fractures. In one study, a 20 microgram dose helped most patients heal faster. Another study found that 67% of participants experienced significant improvement in their fractures. Patients reported quicker healing with teriparatide and few side effects. Early treatment with teriparatide led to good results and reduced the need for surgery. Overall, teriparatide shows promise in shortening recovery time and improving healing for stress fractures. ^{1 5 6 7 8}

Who Is on the Research Team?

James B Jackson, MD

Principal Investigator

University of South Carolina School of Medicine

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive teriparatide or placebo via self-injection daily

12 weeks

Weekly visits (in-person) for monitoring and guidance

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Quarterly visits (in-person)

Long-term follow-up

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

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Teriparatide

Trial Overview

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Eisenhower Army Medical Center

Collaborator

Trials

9

Recruited

720+

Moncrief Army Health Clinic

Collaborator

Trials

1

Recruited

180+

Published Research Related to This Trial

In a study involving 159 patients with femoral neck fractures, teriparatide did not show a significant improvement in reducing the need for revision surgery or enhancing radiographic fracture healing compared to placebo.

The safety profile of teriparatide was consistent with previous findings, as the rate of adverse events was similar between the teriparatide and placebo groups, indicating that it is safe for use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial. Bhandari, M., Jin, L., See, K., et al.[2019]

Recombinant teriparatide (20 microg/day) is effective in increasing bone mineral density and reducing fracture risk in various osteoporosis patients, including postmenopausal women and men with idiopathic or hypogonadal osteoporosis, over a treatment period of 11-21 months.

The positive effects of teriparatide on bone health, including vertebral fracture prevention, continue even after treatment ends, making it a valuable option for high-risk osteoporosis patients, despite its high cost and treatment duration limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on teriparatide in osteoporosis. Blick, SK., Dhillon, S., Keam, SJ.[2016]

Recombinant teriparatide (Forteo) is an effective anabolic treatment for osteoporosis, significantly improving bone mineral density and reducing fracture risk in various patient groups, including postmenopausal women and men with idiopathic or glucocorticoid-induced osteoporosis, over a treatment period of 11-21 months.

Teriparatide is generally well tolerated, but due to treatment duration limits and high costs, it is recommended primarily for patients at high fracture risk or those who do not respond well to other osteoporosis treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teriparatide: a review of its use in osteoporosis. Blick, SK., Dhillon, S., Keam, SJ.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10177009/

Efficacy and Safety of Teriparatide in Improving Fracture ...

The study found that a dose of 20 µg of teriparatide was effective in reducing the time to healing in three out of four cortices, compared to ...

2.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05556-3

Teriparatide and stress fracture healing in young adults ...

(2016) reported 67% of participants who received teriparatide achieved a two grades or more improvement in healing or reduction to grade zero ( ...

3.

asbmr.confex.com

asbmr.confex.com/asbmr/2024/meetingapp.cgi/Paper/3299

Teriparatide is effective in the treatment of stress fractures ...

All patients positively reported that teriparatide improved their healing rate. 3 patients reported self-limiting side effects related to hypercalcemia (2 ...

4.

isakos.com

isakos.com/2025/Abstract/20401

Teriparatide May Be Effective in the Treatment of Stress ...

Early treatment of stress fractures with teriparatide is associated with good efficacy, low recurrence, and low rates of conversion to surgery.

5.

medcraveonline.com

medcraveonline.com/EMIJ/teriparatide-in-athlete-stress-fracture-healing-a-case-report-and-review-of-literature.html

Teriparatide in athlete stress fracture healing: a case ...

Teriparatide shows considerable promise in enhancing the healing of stress fractures in athletes, potentially reducing recovery time and improving functional ...

6.

frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1391356/full

Indications and adverse events of teriparatide

Teriparatide exhibited a stronger association with increased calcium levels (PRR: 50.73) compared to fractures (PRR range: 17.67–552.95).

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2020/021318s053lbl.pdf

FORTEO (teriparatide) Label - accessdata.fda.gov

The safety and efficacy of FORTEO have not been evaluated beyond 2 years of treatment. Consequently, use of the drug for more than 2 years ...

8.

mayoclinic.org

mayoclinic.org/drugs-supplements/teriparatide-subcutaneous-route/description/drg-20066280

Teriparatide (subcutaneous route) - Side effects & dosage

Safety and efficacy have not been established. However, use is not recommended because it may increase the risk for bone cancer in children with ...