NCT02090244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

5.8 years

First QC Date

March 16, 2014

Last Update Submit

April 16, 2019

Conditions

Spinal Stenosis

Keywords

PTHSpinal stenosisTeriparatide

Outcome Measures

Primary Outcomes (1)

  • The rate of bone healing after spinal stenosis surgery

    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 Outcomes (2)

  • Pain

    At 3 and 6 months.

  • Function

    At 3 and 6 months.

Study Arms (2)

Control

NO INTERVENTION

Standard care postoperatively.

Teriparatide

EXPERIMENTAL

One injection daily for 4 weeks

Drug: Teriparatide

Interventions

TeriparatideDRUG

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

Also known as: Forteo
Teriparatide

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • lumbar spinal stenosis operated on with decompression and bone grafting. All ages are accepted, but women must be postmenopausal.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ortopedkliniken

Kalmar, Sweden

Location

Ryggkliniken, US Linköping

Linköping, 581 85, Sweden

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jon Ottesen, MD

    Ryggkliniken, US Linköping

    PRINCIPAL INVESTIGATOR

  • Patrik Bernestrå, MD

    Ortopedkliniken, Kalmar, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 16, 2014

First Posted

March 18, 2014

Study Start

August 1, 2012

Primary Completion

May 1, 2018

Study Completion

January 1, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

SE(2)