Naslov
Unexplained decreasing of rhBMP-2 dose

Autori
Smoljanović, Tomislav ; Pećina, Marko

Izvornik
American Journal of Bone and Joint Surgery

Vrsta, podvrsta
Ostale vrste radova, ostalo

Godina
2007

Ključne riječi
bone morphogenetic protein; spine fusion; bone resorption

Sažetak
In the paper “ Use of rhBMP-2 in combination with structural cortical allografts: clinical and radiographic outcomes in anterior lumbar spinal surgery” , Burkus et al. reported after the end of the pivot phase that 18% (14 of 79) of patients treated with allograft dowels and rhBMP-2 during the single level anterior lumbar interbody fusion had transient localized areas of bone remodeling of the vertebral bodies. Curiously, although the study protocols for the both phases of this therapeutic level 1, two-part, prospective, randomized, multicenter United States Food and Drug Administration-approved investigational device exemption study were identical, there was no report of unanticipated adverse events, i.e. vertebral bone resorption in the pilot study. However, an examination of these studies revealed that the total dose of rhBMP-2 at a concentration of 1.5 mg/mL was different between the two parts of the same study. In the pilot study total dose of rhBMP-2 per level of fusion was reported to be 8 to 12 mL, i.e. 12 to 18 mg, whereas in the pivot study it was 8.4 to 12 mg. The recent findings reveal that rhBMP-2 stimulates osteoclast formation and dentin resorption by osteoclasts in dose depended manner. Furthermore, higher doses of BMP-2 preserved higher levels of resorption and for longer period of time than lower doses. Even if we pass over the fact that there was no report of unanticipated adverse effects in the pilot study compared to pivot study, it is hard to explain the appearance of vertebral bone resorptions when total dose of rhBMP-2 was 30% smaller.

Izvorni jezik
Engleski

Znanstvena područja
Temeljne medicinske znanosti, Kliničke medicinske znanosti

POVEZANOST RADA