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

Sponsor
University Hospital, Linkoeping (Other)
Overall Status
Completed
CT.gov ID
NCT02090244
Collaborator
Medical Research Council of Southeast Sweden (Other)
34
Enrollment
2
Locations
2
Arms
77
Actual Duration (Months)
17
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?
Actual Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Pain [At 3 and 6 months.]

      Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ortopedkliniken Kalmar Sweden
    2 Ryggkliniken, US Linköping Linköping Sweden 581 85

    Sponsors and Collaborators

    • University Hospital, Linkoeping
    • Medical Research Council of Southeast Sweden

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Torsten Johansson, MD, PhD, University Hospital, Linkoeping
    ClinicalTrials.gov Identifier:
    NCT02090244
    Other Study ID Numbers:
    • PTH spinal stenosis
    • 2011-002917-12
    First Posted:
    Mar 18, 2014
    Last Update Posted:
    Apr 17, 2019
    Last Verified:
    Apr 1, 2019
    Keywords provided by Torsten Johansson, MD, PhD, University Hospital, Linkoeping
    PTH
    Spinal stenosis
    Teriparatide
    Additional relevant MeSH terms:
    Spinal Stenosis
    Teriparatide

    Study Results

    No Results Posted as of Apr 17, 2019