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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard care postoperatively. | |
| Experimental: Teriparatide<br>One injection daily for 4 weeks | Drug: Teriparatide<br>* Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks<br>* Other names: Forteo;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTH, Spinal stenosis, Teriparatide