Trial | NCT02090244  Report issue

Title

Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    34
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.
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 Started
Aug 31
2012
Primary Completion
May 31
2018
Study Completion
Jan 01
2019
Last Update
Apr 17
2019

Drug Teriparatide

Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks

  • Other names: Forteo

Control No Intervention

Standard care postoperatively.

Teriparatide Experimental

One injection daily for 4 weeks

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)
No Results Posted