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

University Hospital, Linkoeping

Status and phase

Completed

Phase 4

Conditions

Spinal Stenosis

Treatments

Drug: Teriparatide

Study type

Interventional

Funder types

Other

Identifiers

NCT02090244

2011-002917-12 (EudraCT Number)

PTH spinal stenosis

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Volunteers

No Healthy Volunteers

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)