Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion

What Was Tested

This registered phase 4 trial tested Teriparatide.

The purpose of this study is to determine the effects of 12 weeks of daily treatment with teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral spine fusion surgery for degenerative conditions of the lumbar spine.

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

Saline placebo.

The registry classes the interventions as biological.

More on the Plan

For patients undergoing spine fusion surgery, non-fusion (or pseudarthrosis) is one of the major complications that can lead to poor clinical outcomes.

Therefore, treatments that promote or augment fusion are highly desirable.

Teriparatide (Forteo, recombinant human parathyroid hormone \[1-34\]) is a systemically administered peptide hormone that is FDA-approved for the treatment of osteoporosis in postmenopausal women or other populations at high risk for fracture.

While Forteo is FDA approved, and IND is required for this trial to study an unapproved indication: Posterolateral Lumbar Spine Fusion.

Who Took Part

36 actual participants took part.

It was open to people of any sex aged from 60 years up to 90 years.

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

Examples of who could join: Willing and able to use a pen-type delivery system to administer daily subcutaneous injections.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: use of bone morphogenic protein (bmp) posterolaterally during the fusion procedure; previous spinal fusion at the intended fusion levels; prior use of forteo (teriparatide).

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.

Neither the participants nor the staff measuring them knew who was on Teriparatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2011-08 with completion listed for 2015-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year (time frame: One year). Time to Spine Fusion (time frame: One year).

It also tracked 2 secondary outcomes, for example Adverse Effects.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 36 people.

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, all human trials.