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

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ClinicalTrials.gov Identifier: NCT02090244
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Medical Research Council of Southeast Sweden
Information provided by (Responsible Party):
Torsten Johansson, University Hospital, Linkoeping

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
Spinal Stenosis Drug: Teriparatide 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.


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Study Type : Interventional  (Clinical Trial)
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 : August 2012
Actual Primary Completion Date : May 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

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 Name: Forteo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090244


Locations
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Sweden
Ortopedkliniken
Kalmar, Sweden
Ryggkliniken, US Linköping
Linköping, Sweden, 581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Medical Research Council of Southeast Sweden
Investigators
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Principal Investigator: Jon Ottesen, MD Ryggkliniken, US Linköping
Principal Investigator: Patrik Bernestrå, MD Ortopedkliniken, Kalmar, Sweden

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Responsible Party: Torsten Johansson, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT02090244     History of Changes
Other Study ID Numbers: PTH spinal stenosis
2011-002917-12 ( EudraCT Number )
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

Keywords provided by Torsten Johansson, University Hospital, Linkoeping:
PTH
Spinal stenosis
Teriparatide

Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents