Bezeotermin Alfa (rhBMP-6) Administration in Lumbar Interbody Fusion Surgery Using a Posterior Approach
Bibliographic record
Abstract
BACKGROUND: Novel osteoconductive and osteoinductive therapies for posterior-based lumbar interbody fusion surgery are needed. Bezeotermin alfa (recombinant human bone morphogenetic protein [rhBMP]-6, previously referred to as AGA111) is a potential potent stimulator of bone regeneration. This prospective, multicenter, randomized, double-blinded, placebo-controlled Phase-2 trial evaluated the safety and preliminary efficacy of bezeotermin carried by autologous blood coagulum (ABC) in patients undergoing lumbar interbody fusion surgery between L3 and S1 for degenerative disc disease. METHODS: Adult patients scheduled for single-level elective lumbar interbody fusion surgery across 6 clinical trial sites in the People's Republic of China were randomized 1:1:1 to placebo, 0.25 mg bezeotermin, or 0.5 mg bezeotermin and followed for 12 months. The primary end point was the incidence of adverse events (AEs). Secondary end points included anti-rhBMP-6 antibodies, the success rate of radiographic fusion, changes in the Oswestry Disability Index (ODI) score, changes in the pain score on a visual analogue scale (VAS), and serum drug concentrations. RESULTS: Sixty-three patients with a mean age of 59.2 years (52% female, 98.4% Han) were enrolled in the study. Twenty-one, 20, and 22 of the patients were randomized to placebo, 0.25 mg bezeotermin, and 0.5 mg bezeotermin, respectively. All patients reported at least 1 AE during the study, but most AEs were mild to moderate in severity. No drug-related serious AEs were reported in the bezeotermin groups. There was a trend toward a higher rate of successful radiographic fusion and greater improvement of the ODI and VAS scores in the bezeotermin groups than in the placebo group from month 3 to month 12. CONCLUSIONS: This prospective, randomized, double-blinded, placebo-controlled trial demonstrated that bezeotermin/ABC was safe and well tolerated during posterior-based single-level lumbar interbody fusion. The preliminary efficacy of bezeotermin in accelerating spinal fusion and improving clinical outcomes supports its further clinical development. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".