The Use of Teriparatide as an Adjunctive Therapy for the Treatment of Jones Fractures

What Was Tested

The trial (phase 4) is built around Teriparatide.

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

The registry classes the interventions as drug.

Who Took Part

38 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients who are at least 18 years of age and who have closed epiphyses. Patients of both genders and all races. Patients with Jones fractures of the fifth metatarsal less than 2 weeks prior to presenting for clinical evaluation. Patients with either no prodromal symptoms or prodromal symptoms present less than 2 weeks. Patients with a baseline visual analog scale (VAS) pain score ≤ 20 (100mm scale) for the fifth metatarsal, with the foot at rest and not bearing weight.

The full record lists 9 inclusion and 16 exclusion criteria; among the exclusions: patients who are younger than 18 years of age or patients who are 18 years of age or older with open epiphyses; patients with jones fractures of the fifth metatarsal greater than 2 weeks prior to presenting for clinical evaluation; patients with tuberosity avulsion fractures or fifth metatarsal shaft fractures.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

Those kept unaware of assignments: participant and investigator.

It started in 2010-07 with completion listed for 2014-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Fracture healing (time frame: weeks 4 through 24 after start of treatment).

It also tracked 4 secondary outcomes, for example Pain, Range of Motion, Function and Return to Activity.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 38 people.

Its size is small, so on its own it can only give an early look.

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

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