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

Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02090244

Enrollment

Registered

2014-03-18

Start date

2012-08-31

Completion date

2019-01-01

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Stenosis

Keywords

PTH, Spinal stenosis, Teriparatide

Brief summary

Parathyroid (PTH) hormone has been shown to enhance fracture healing in animal studies. There are so far only three published papers concerning humans. Postero-lateral fusions have shown a healing rate of less than 50% after bone. The purpose of this study is to determine if PTH 1-34 (teriparatide) improves the healing rate and the clinical course after spinal stenosis surgery.

Detailed description

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.

Interventions

DRUGTeriparatide

Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* lumbar spinal stenosis operated on with decompression and bone grafting. All ages are accepted, but women must be postmenopausal.

Exclusion criteria

* •dementia or psychiatric disorder * known malignancy \< 5 years prior to fracture * calcium above reference value * signs of liver disease * creatinine over ref. value * inflammatory joint disease * alcohol or drug abuse * oral corticosteroid medication * long-term NSAID-treatment (=\> 3 months prior to fracture)

Design outcomes

Primary

Measure	Time frame	Description
The rate of bone healing after spinal stenosis surgery	6 months + more than 2 years postoperatively.	A radiologist, blinded to the treatment, will review all CT scans and judge whether there is a bony healing between the vertebrae.

Secondary

Measure	Time frame	Description
Pain	At 3 and 6 months.	Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.
Function	At 3 and 6 months.	Function is evaluated using Oswestry Disability Index. Zero is equated with no disability and 100 is the maximum disability possible.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026