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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT02090244 (opens ClinicalTrials.gov in a new tab)Other idPTH spinal stenosisOther id2011-002917-12
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Overview

Status
Completed
Phase
Phase 4
Enrollment
34 participants (actual)
Sponsor
University Hospital, Linkoeping · Other
Design
Randomized · Single masking
Countries
1 country

Sweden

Start
Aug 2012
Primary completion
May 2018
Completion
1 Jan 2019
First posted
18 Mar 2014 (estimated)
Last update posted
17 Apr 2019
Conditions
Spinal Stenosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122014201620182020
  1. Ph 4

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

    NCT02090244

    Aug 2012 to 1 Jan 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeriparatideDrug

Arms2

  • No intervention

    Control

    Standard care postoperatively.

  • Experimental

    Teriparatide

    One injection daily for 4 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The rate of bone healing after spinal stenosis surgery

    Time frame · 6 months + more than 2 years postoperatively.

    Registry description

    A radiologist, blinded to the treatment, will review all CT scans and judge whether there is a bony healing between the vertebrae.

Secondary outcomes(2)

  1. Pain

    Time frame · At 3 and 6 months.

    Registry description

    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.

    Registry description

    Function is evaluated using Oswestry Disability Index. Zero is equated with no disability and 100 is the maximum disability possible.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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