Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?

What Was Tested

This registered phase 4 trial tested Teriparatide.

There are so far only three published papers concerning humans.

It had two arms (groups): Control (no intervention) and Teriparatide (experimental).

Standard care postoperatively.

One injection daily for 4 weeks.

The registry classes the interventions as drug.

More on the Plan

100 patients undergoing surgery due to spinal stenosis and intraoperatively treated with autologous bone graft, will be randomised to either 4 weeks of daily injections with teriparatide or control.

Primary outcome: The rate of healing at 6 months on CT Scans.

Secondary outcomes; Pain (VAS), function (Oswestry Disability Index), quality of life (EQ-5D) at 3 and 6 months.

Who Took Part

34 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Lumbar spinal stenosis operated on with decompression and bone grafting. All ages are accepted, but women must be postmenopausal.

The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: •dementia or psychiatric disorder; known malignancy \< 5 years prior to fracture; calcium above reference value.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Teriparatide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2012-08 with completion listed for 2018-05.

It ran at 2 sites in Sweden (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The rate of bone healing after spinal stenosis surgery (time frame: 6 months + more than 2 years postoperatively).

It also tracked 2 secondary outcomes, for example Pain and Function.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 34 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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