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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
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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.
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