Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
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|ClinicalTrials.gov Identifier: NCT02090244|
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Stenosis||Drug: Teriparatide||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?|
|Actual Study Start Date :||August 2012|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||January 1, 2019|
No Intervention: Control
Standard care postoperatively.
One injection daily for 4 weeks
Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks
Other Name: Forteo
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090244
|Ryggkliniken, US Linköping|
|Linköping, Sweden, 581 85|
|Principal Investigator:||Jon Ottesen, MD||Ryggkliniken, US Linköping|
|Principal Investigator:||Patrik Bernestrå, MD||Ortopedkliniken, Kalmar, Sweden|