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

Phase 4

Completed

• Conditions: Spinal Stenosis
• Interventions: Drug: Teriparatide

• Registration Number: NCT02090244
• Lead Sponsor: University Hospital, Linkoeping

Brief 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.

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2014-03-16
• Study First Submitted QC: 2014-03-16
• Study First Posted: 2014-03-18
• Primary Completion: 2018-05
• Study Completion: 2019-01-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teriparatide	Teriparatide	One injection daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Ryggkliniken, US Linköping; 🇸🇪 Linköping, Sweden

Ortopedkliniken; 🇸🇪 Kalmar, Sweden