Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?

NCT02090244 — Phase 4, Completed, 34 participants, University Hospital, Linkoeping

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Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?

Registry	NCT02090244
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	34 (Actual)
Sponsor	University Hospital, Linkoeping (Other); collaborators: Medical Research Council of Southeast Sweden
Conditions	Spinal Stenosis
Interventions	Teriparatide (Drug)
Dates	start 2012-08-01, primary completion 2018-05-01, completion 2019-01-01, first posted 2014-03-18, last updated 2019-04-17
Locations	2 sites in Sweden

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Control	No intervention		Standard care postoperatively.
Teriparatide	Experimental	Drug: Teriparatide	One injection daily for 4 weeks

Teriparatide (Drug), also known as Forteo: Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks

+Outcome measures

Primary outcomes

The rate of bone healing after spinal stenosis surgery [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.

Secondary outcomes

Pain [At 3 and 6 months.]: Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.
Function [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.

+Eligibility

Sex: All

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 (2)

Facility	City	Country	Status
Ortopedkliniken	Kalmar	Sweden
Ryggkliniken, US Linköping	Linköping	Sweden

+Investigators

Jon Ottesen, MD, Principal investigator, Ryggkliniken, US Linköping
Patrik Bernestrå, MD, Principal investigator, Ortopedkliniken, Kalmar, Sweden

My Notes

Public

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