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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2019-01-01

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.

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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.

Conditions

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Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Standard care postoperatively.

Group Type NO_INTERVENTION

No interventions assigned to this group

Teriparatide

One injection daily for 4 weeks

Group Type EXPERIMENTAL

Teriparatide

Intervention Type DRUG

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

Interventions

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Teriparatide

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

Intervention Type DRUG

Other Intervention Names

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Forteo

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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No