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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: Frbttrar PTH Postero-lateral fusionslkning 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

Page last updated: August 20, 2015

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