Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial

What Was Tested

This registered phase 4 trial tested Teriparatide for rheumatoid arthritis.

Specifically, the investigators will examine whether teriparatide in combination with a biologic can retard the development of joint erosions.

It had two arms (groups): Teriparatide (experimental) and Control Arm (other).

The registry classes the interventions as drug.

More on the Plan

Introduction: While generalized osteoporosis causes tremendous disability in patients with Rheumatoid Arthritis (RA) and occurs relatively frequently in such patients, there has been little research on treatments for osteoporosis in patients with RA.

Not only are there important questions about the effects of teriparatide on Bone Mineral Density (BMD) in patients with RA, but little is known about how it might affect localized bone erosions or RA disease activity.

That is the primary aim of the proposed study.

Objectives and Hypotheses: To assess the effects of teriparatide among a group of patients with RA and erosions, all using biologics, with respect to: 1.

Who Took Part

The registry lists 26 actual participants took part.

It was open to people of any sex aged from 45 years with no upper age limit.

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

Examples of who could join: RA will be defined according to the 2010 American College of Rheumatology/European League Against Rheumatism diagnostic and classification criteria. Subjects must be able to give written informed consent.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

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

Being open-label, the Teriparatide study did not mask who received what.

It started in 2011-08 with completion listed for 2015-07-30.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan (time frame: Baseline and Month 12).

It also tracked 2 secondary outcomes, for example Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 26 people with rheumatoid arthritis.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, Rheumatoid arthritis research.