Back to resultsDoes PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
Primary Purpose
Spinal Stenosis
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Teriparatide
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis focused on measuring PTH, Spinal stenosis, Teriparatide
Eligibility 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)
Sites / Locations
- Ortopedkliniken
- Ryggkliniken, US Linköping
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Teriparatide
Arm Description
Standard care postoperatively.
One injection daily for 4 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain
Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.
Function
Function is evaluated using Oswestry Disability Index. Zero is equated with no disability and 100 is the maximum disability possible.
Full Information
NCT ID
NCT02090244
First Posted
March 16, 2014
Last Updated
April 16, 2019
Sponsor
University Hospital, Linkoeping
Collaborators
Medical Research Council of Southeast Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02090244
Brief Title
Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
Official Title
Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
Collaborators
Medical Research Council of Southeast Sweden
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
Keywords
PTH, Spinal stenosis, Teriparatide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care postoperatively.
Arm Title
Teriparatide
Arm Type
Experimental
Arm Description
One injection daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
Forteo
Intervention Description
Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks
Primary Outcome Measure Information:
Title
The rate of bone healing after spinal stenosis surgery
Description
A radiologist, blinded to the treatment, will review all CT scans and judge whether there is a bony healing between the vertebrae.
Time Frame
6 months + more than 2 years postoperatively.
Secondary Outcome Measure Information:
Title
Pain
Description
Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.
Time Frame
At 3 and 6 months.
Title
Function
Description
Function is evaluated using Oswestry Disability Index. Zero is equated with no disability and 100 is the maximum disability possible.
Time Frame
At 3 and 6 months.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Ottesen, MD
Organizational Affiliation
Ryggkliniken, US Linköping
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrik Bernestrå, MD
Organizational Affiliation
Ortopedkliniken, Kalmar, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ortopedkliniken
City
Kalmar
Country
Sweden
Facility Name
Ryggkliniken, US Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
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