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NCT02090244·Phase 4·INTERVENTIONAL

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

TeriparatideOtherCompleted

Status

Completed

Phase

Phase 4

Enrollment

34

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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 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.

Interventions

Treatment arms and agents.

DRUG

Teriparatide

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

Timeline

From registration to results.

  1. First posted

    Mar 18, 2014

  2. Study start

    Aug 2012

  3. Primary completion

    May 2018

  4. Study completion

    Jan 1, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Apr 17, 2019

Outcomes

What the study measures.

Primary outcomes

The rate of bone healing after spinal stenosis surgery

Time frame · 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

Time frame · At 3 and 6 months.

Pain is evaluated using VAS (Visual analogue scale). Zero means no pain and 10 is maximal pain.

Function

Time frame · 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

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

2 registered sites.

Sweden. Showing up to 24 locations stored in the fast local snapshot.

Ortopedkliniken

Kalmar, Sweden

Ryggkliniken, US Linköping

Linköping, Sweden

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Teriparatide.

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

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