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

Spinal Stenosis Clinical Trial

Official title:

Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090244
• Other study ID #: PTH spinal stenosis
• Secondary ID: 2011-002917-12
• Status: Completed
• Phase: Phase 4
• Start date: August 2012
• Est. completion date: January 1, 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 1, 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
Sweden	Ortopedkliniken	Kalmar
Sweden	Ryggkliniken, US Linköping	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Medical Research Council of Southeast Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of bone healing after spinal stenosis surgery	A radiologist, blinded to the treatment, will review all CT scans and judge whether there is a bony healing between the vertebrae.	6 months + more than 2 years postoperatively.
Secondary	Pain	Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.	At 3 and 6 months.
Secondary	Function	Function is evaluated using Oswestry Disability Index. Zero is equated with no disability and 100 is the maximum disability possible.	At 3 and 6 months.