Trials / Completed
CompletedNCT02090244
Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- University Hospital, Linkoeping · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Teriparatide | Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2018-05-01
- Completion
- 2019-01-01
- First posted
- 2014-03-18
- Last updated
- 2019-04-17
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT02090244. Inclusion in this directory is not an endorsement.