Preoperative Teriparatide Use on Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery

What Was Tested

This registered not phased trial tested Teriparatide.

This project aims to investigate any difference of insertional torque strength for osteoporotic patients with preoperative 1-month teriparatide injections versus those without.

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

Recruitment for fusion surgery as usual.

Preoperative 1 month use of teriparatide, before lumbar fusion surgery.

The registry classes the interventions as drug.

More on the Plan

For this project, adult patients (\>40 years) undergoing lumbar spinal fusion will be randomized to undergo teriparatide treatment for 1 month prior to surgery.

Patients will have their baseline BMD assessed by DEXA scan must be considered as osteoporotic (\>2.5 SD from sex-matched young adult, or previous vertebral and/or femoral fractures) and indicated for spinal fusion surgery to undergo study.

Exclusion criteria included Paget disease of bone, high laboratory tests for serum alkaline phosphatase or calcium, previous radiation treatment or fusion surgery to lumbar spine, bone tumors, metabolic bone disease, and hypersensitivity to teriparatide.

Surgery involving single- or multi-level lumbar spinal fusion for any of the conditions: lumbar spinal stenosis, degenerative/isthmic/congenital spondylolisthesis, degenerative scoliosis.

Who Took Part

192 planned participants were the target.

It was open to people of any sex aged from 40 years up to 100 years.

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

The full record lists 1 inclusion and 1 exclusion criteria.

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.

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

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

It started in 2019-03-01 with completion listed for 2026-03-31.

It ran at 3 sites in Hong Kong (3).

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Insertional torque Intraoperative insertional torque measurement (time frame: Intraoperative).

It also tracked 11 secondary outcomes, for example Bone Mineral Density (BMD), Complication rate, Fusion rate, EQ-5D-5L, Oswestry Disability Index (ODI) and Short form 36-item questionnaire (SF-36).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Teriparatide in 192 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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