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Completed

NCT Number: NCT02090244

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

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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Key information

Conditions

Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ortopedkliniken, Kalmar, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Teriparatide

Drug

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

Other names: Forteo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Collaborators

  • Medical Research Council of Southeast Sweden

Registry information

Official study title

Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Mar 18, 2014
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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