What is the mechanism of action of this treatment?

Common treatments for stress fractures of the tibia or fibula include bisphosphonates and teriparatide. Bisphosphonates inhibit osteoclast-mediated bone resorption, helping to maintain bone density and strength. Teriparatide stimulates osteoblast activity, promoting new bone formation and accelerating fracture healing. These mechanisms are important for patients as they can reduce healing time, improve bone strength, and decrease the risk of future fractures.

What side effects are associated with this type of intervention?

Teriparatide, used to accelerate bone healing in stress fractures, can cause side effects such as nausea, dizziness, leg cramps, and an increased risk of osteosarcoma with long-term use. Bisphosphonates, another common treatment, may lead to gastrointestinal issues, musculoskeletal pain, and, rarely, osteonecrosis of the jaw. Both treatments are generally well-tolerated but should be monitored for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoporosis that may be relevant for stress fractures of the tibia or fibula, focusing on agents that stimulate bone healing. Teriparatide, an osteoanabolic agent, has shown positive impacts on fracture healing by stimulating osteoblast activity. Bisphosphonates, such as alendronate and zoledronic acid, are also approved for osteoporosis treatment and have been studied for their effects on fracture healing, although their primary role is in preventing bone loss rather than directly accelerating healing. These treatments are part of ongoing research to improve outcomes for patients with stress fractures.

What other types of research exist?

Promising novel alternatives to Teriparatide for stress fractures of the tibia or fibula include: 1) Romosozumab, a monoclonal antibody that inhibits sclerostin and promotes bone formation, and 2) Abaloparatide, a parathyroid hormone-related protein analog that stimulates osteoblast activity. Both have shown efficacy in increasing bone mineral density and reducing fracture risk.

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Osteoporosis Agent

Teriparatide for Stress Fractures

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

Skeletally mature

Willing to self-administer study medication

Must not have

Paget's disease of bone

History of any form of cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Teriparatide may cause side effects such as nausea, dizziness (especially when getting up), leg cramps or pain at the injection site. There might also be an increased risk of developing kidney stones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bones have stopped growing.

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I am willing to take my own study medication.

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I am a soldier diagnosed with a shin bone stress injury needing time off.

Exclusion Criteria

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

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I have Paget's disease of bone.

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I have had cancer in the past.

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I experience significant drops in blood pressure when standing up.

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I have had radiation therapy targeting my bones.

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My growth plates are still open.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluation of long-term effects of the administration of teriparatide

Evaluation of long-term effects of the administration of teriparatide on injury recurrence

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

+1 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.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TeriparatideActive Control1 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: PlaceboPlacebo Group1 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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stress fractures of the tibia or fibula include bisphosphonates and teriparatide. Bisphosphonates inhibit osteoclast-mediated bone resorption, helping to maintain bone density and strength. Teriparatide stimulates osteoblast activity, promoting new bone formation and accelerating fracture healing. These mechanisms are important for patients as they can reduce healing time, improve bone strength, and decrease the risk of future fractures.

A literature review and case series of accelerating fracture healing in postmenopausal osteoporotic working women.