Fracture Recovery for Returning to Duty (Teriparatide STRONG)

What Was Tested

The trial (phase 4) is built around Teriparatide.

It had two arms (groups): Teriparatide (active comparator) and Placebo (placebo comparator).

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.

The registry classes the interventions as drug.

More on the Plan

The study will examine the utility of a novel, non-operative, anabolic bone agent in the treatment of diaphyseal tibial stress fractures (DTSF).

This allowed the medication to gain it an FDA indication for treatment in these groups.

The investigators seek to explore additional uses for this anabolic agent in an at risk study population that has an imbalance of bone stress and bone formation resulting in a bone stress injury (BSI).

A powered, prospective, controlled randomized study design will be utilized.

Who Took Part

Enrollment: 183 planned participants were the target.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Soldiers actively enlisted in the U.S. Army attached to basic training unit at Fort Jackson. Soldiers diagnosed with a tibial diaphyseal BSI requiring convalescent leave. Willing to self-administer study medication. Desire to continue their military commitment.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: history of any form of cancer; currently pregnant; paget's disease of bone.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

The Teriparatide group and the comparison group ran side by side rather than switching.

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-12-08 with completion listed for 2026-12-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time from diagnosis to full return to activity (time frame: 3 years). Evaluation of long-term effects of the administration of teriparatide (time frame: 3 years). Evaluation of long-term effects of the administration of teriparatide on injury recurrence (time frame: 3 years).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 183 people.

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, all human trials.