Project Details
Description
This is the first trial of Osteogrow (rhBMP6/ABC) with local lumbar intertransverse processes administration. It is a randomized, patient and evaluator blinded, controlled trial conducted in Phase II clinical development. 192 patients will be recruited in 3 Austrian centers. Safety and composite endpoint non-inferiority of two doses of Osteogrow+Allograft delivered bilaterally between transverse processes of a single lumbar spine segment in comparison to autologous iliac crest bone graft will be evaluated.
| Acronym | OSTEOproSPINE |
|---|---|
| Status | Finished |
| Effective start/end date | 01.01.2018 → 30.06.2023 |
Collaborative partners
- Johannes Kepler University Linz
- Kepler Universitätsklinikum GmbH (Project partner)
- University of Zagreb School of Medicine (Coordinator) (lead)
- Genera Istrazivanja Drustvo s Ogranicenom Odgovornoscu za Proizvodnju Biotehnoloskih Proizvoda (Project partner)
- Medical University of Vienna (Project partner)
- Medical University of Graz (Project partner)
- Opca Bolnica Varazdin (Project partner)
- Paul Regulatory Services Limited (Project partner)
- Clinres Farmacija Raziskave Doo (Project partner)
- Smart-Medico Doo (Project partner)
- Triadelta Partneri Doo za Istrazivanje i Razvoj (Project partner)
- 2KMM Spolka z Ograniczona Odpowiedzialnoscia (Project partner)
- Universität Zagreb - Veterinärmedizinische Fakultät (Project partner)
- Eurice European Research an Project Office GmbH (Project partner)
- QBEX GmbH (Project partner)
Fields of science
- 302051 Neurosurgery