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

183 Participants Needed

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.

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 evidence supports the effectiveness of the drug Teriparatide for stress fractures?

Teriparatide is known to improve bone healing and strength in conditions like osteoporosis, and preliminary data suggest it may also help with bone healing in stress fractures. ^{1 2 3 4 5}

Is teriparatide safe for humans?

Teriparatide, also known as Forteo, has been used safely by over 430,000 patients since its approval in 2002. Although there was initial concern about a potential risk of bone cancer (osteosarcoma) based on animal studies, large human studies have not shown an increased risk, leading to the removal of the boxed warning about this risk in 2020. ^{3 6 7 8 9}

How is the drug Teriparatide unique for treating stress fractures?

Teriparatide is unique because it is a bone-building drug that mimics a natural hormone to enhance bone healing, unlike other treatments that may not directly stimulate bone growth. It is typically used for osteoporosis but is being studied for its potential to speed up the healing of stress fractures, which is not a standard use for most other treatments. ^{1 2 3 5 10}

Research Team

James B Jackson, MD

Principal Investigator

University of South Carolina School of Medicine

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Teriparatide: a review of its use in osteoporosis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Teriparatide and stress fracture healing in young adults (RETURN - Research on Efficacy of Teriparatide Use in the Return of recruits to Normal duty): study protocol for a randomised controlled trial. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on teriparatide in osteoporosis. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Rapid progression of aortic stenosis after initiation of teriparatide treatment: a case report. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Of mice and men: divergent risks of teriparatide-induced osteosarcoma. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Teriparatide and Osteosarcoma Risk: History, Science, Elimination of Boxed Warning, and Other Label Updates. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Long-term cancer surveillance: results from the Forteo Patient Registry Surveillance Study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The Forteo Patient Registry linkage to multiple state cancer registries: study design and results from the first 8 years. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Periprosthetic Femoral Stress Fracture After Bisphosphonate Treatment Resulting in Nonunion Successfully Treated with Teriparatide: A Case Report. [2021]