Spinal StenosisPhase 4NCT02090244
Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
A Phase 4 study testing Teriparatide in people with Spinal Stenosis, run by University Hospital, Linkoeping at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesSweden
- Study dates
- Aug 2012to 1 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- lumbar spinal stenosis operated on with decompression and bone grafting. All ages are accepted, but women must be postmenopausal.
Who cannot join
- •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
Show all 9Show fewer
- alcohol or drug abuse
- oral corticosteroid medication
- long-term NSAID-treatment (=> 3 months prior to fracture)
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Ortopedkliniken
Kalmar
Ryggkliniken, US Linköping
Linköping, 581 85
About this study
Official title: Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?
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.
Read the 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.
- Conditions
- Spinal Stenosis
- Being tested
- Teriparatide
- Keywords
- PTH, Spinal stenosis, Teriparatide
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo
Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard care postoperatively. |
| Teriparatide | Experimental | One injection daily for 4 weeks Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months + more than 2 years postoperatively.
Secondary outcomes (2)
Pain
Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.
Measured: At 3 and 6 months.
Function
Function is evaluated using Oswestry Disability Index. Zero is equated with no disability and 100 is the maximum disability possible.
Measured: At 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startAug 2012
- Primary completionMay 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council of Southeast Sweden
- Responsible party
- Principal investigator, Torsten Johansson, University Hospital, Linkoeping
- Investigators
- Jon Ottesen, MD, Principal investigator, Ryggkliniken, US LinköpingPatrik Bernestrå, MD, Principal investigator, Ortopedkliniken, Kalmar, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090244
- Sponsor's protocol ID
- PTH spinal stenosis
- Other IDs
- 2011-002917-12
- Status last verified
- Apr 2019
- First submitted
- 16 Mar 2014
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?
- ClinicalTrials.gov ID
- NCT02090244
- Acronym / sponsor ID
- PTH spinal stenosis
- Conditions
- Spinal Stenosis
- Keywords
- PTH, Spinal stenosis, Teriparatide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Medical Research Council of Southeast Sweden
- Study start
- Aug 2012 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard care postoperatively. |
| Teriparatide | Experimental | Drug: TeriparatideOne injection daily for 4 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- lumbar spinal stenosis operated on with decompression and bone grafting. All ages are accepted, but women must be postmenopausal.
Key exclusion criteria (9 listed)
- •dementia or psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriparatideAlso: ForteoDaily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks | Drug | Teriparatide |
Primary outcome
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.
2 secondary outcomes
Pain
Time frame: At 3 and 6 months.
Function
Time frame: At 3 and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Ottesen, MD principal investigator
Ryggkliniken, US Linköping
Patrik Bernestrå, MD principal investigator
Ortopedkliniken, Kalmar, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teriparatide in people with Spinal Stenosis, run by University Hospital, Linkoeping at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of bone healing after spinal stenosis surgery (time frame: 6 months + more than 2 years postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.