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

April 16, 2019 updated by: Torsten Johansson, University Hospital, Linkoeping

Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Kalmar, Sweden
        • Ortopedkliniken
      • Linköping, Sweden, 581 85
        • Ryggkliniken, US Linköping

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of bone healing after spinal stenosis surgery
Time Frame: 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.
6 months + more than 2 years postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: At 3 and 6 months.
Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.
At 3 and 6 months.
Function
Time Frame: 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.
At 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Collaborators

Medical Research Council of Southeast Sweden

Investigators

  • Principal Investigator: Jon Ottesen, MD, Ryggkliniken, US Linköping
  • Principal Investigator: Patrik Bernestrå, MD, Ortopedkliniken, Kalmar, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

March 16, 2014

First Submitted That Met QC Criteria

March 16, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTH spinal stenosis
  • 2011-002917-12 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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