Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
Information source: University Hospital, Linkoeping
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Stenosis
Intervention: Teriparatide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Linkoeping Official(s) and/or principal investigator(s):
Jon Ottesen, MD, Principal Investigator, Affiliation: Ryggkliniken, US Linköping
Patrik Bernestrå, MD, Principal Investigator, Affiliation: Ortopedkliniken, Kalmar, Sweden
Overall contact:
Torsten Johansson, MD PhD, Phone: +46-10-1034262, Email: torsten.johansson@lio.se
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.
Clinical Details
Official title: Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The rate of bone healing 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Torsten Johansson, MD PhD, Phone: +46-10-1034262, Email: torsten.johansson@lio.se
Ortopedkliniken, Kalmar, Sweden; Recruiting
Patrik Bernestrå, MD, Phone: +46-48081332, Email: patrik.bernestra@ltkalmar.se
Patrik Bernestra, MD, Principal Investigator
Ryggkliniken, US Linköping, Linköping 581 85, Sweden; Recruiting
Jon Ottesen, MD, Email: jon.ottesen@lio.se
Jon Ottesen, MD, Principal Investigator
Additional Information
Starting date: August 2012
Last updated: December 9, 2014
|
