Oral Food Supplement with Bio-Activated Silicium and Vitamins D3 and K2 in the Conservative Management of Osteoporotic Vertebral Compression Fractures

Abstract

Background: Osteoporotic vertebral compression fractures (OVCFs) are the most prevalent manifestation of osteoporotic skeletal disease, associated with severe pain, functional decline, and elevated risk of subsequent fractures. Conservative management remains the first-line approach for stable fractures, yet pain control is often suboptimal, and vertebral collapse progresses in up to 37% of patients. Bio-activated orthosilicic acid combined with vitamins D3 and K2 (BioSi-DK) may support fracture healing through complementary mechanisms acting on osteoblast differentiation, collagen synthesis, osteocalcin carboxylation, and mineralization, but its clinical efficacy in OVCFs has not previously been investigated. Methods: A retrospective, multi-center comparative cohort study was conducted in patients aged >50 years with DXA-confirmed osteoporosis and acute thoracolumbar OVCFs (AO Spine OF1-OF2) managed conservatively. Patients receiving BioSi-DK supplementation (two capsules daily for two months, then one capsule daily for four months) in addition to standard conservative treatment were compared with controls receiving conservative treatment alone. Propensity score matching (1:1, sex-exact constraint, caliper 0.3 SD) was applied across twelve pre-specified baseline covariates. The primary outcome was pain intensity at six months, assessed by numerical rating scale (NRS). Secondary outcomes included NRS change, analgesic use, Patient Global Impression of Change (PGIC), requirement for vertebral augmentation (kyphoplasty), MRI marrow edema score (MES), and Genant grade change. Results: After propensity score matching, 38 patients (19 per group) with balanced baseline characteristics were analyzed (mean age 71.2 ± 6.5 years; 89.5% female; mean T-score -2.61 ± 0.32; mean baseline NRS 8.26 ± 0.95). The BioSi-DK group achieved a significantly lower post-treatment NRS score compared with controls (2.05 ± 2.17 vs. 3.84 ± 2.83; p = 0.015; Cohen's d = -0.71) and a significantly greater mean NRS reduction (-6.21 ± 1.90 vs. -4.42 ± 2.12 points; p = 0.005; d = -0.89). Analgesic discontinuation was more frequent in the BioSi-DK group (68.4% vs. 36.8%; p = 0.068). Kyphoplasty was required in 5.3% of BioSi-DK patients versus 21.1% of controls (p = 0.340; OR = 0.21), and vertebral compression grade remained stable in 100% of supplemented patients versus 84% of controls. At two months, MES improvement by at least one category was more frequently observed in the BioSi-DK group than in controls, suggesting an earlier edema resolution effect; at six months, MES distribution was comparable between groups (p = 0.620). Conclusions: BioSi-DK supplementation as an adjunct to conservative management was associated with a statistically significant and clinically large reduction in pain at six months, with favorable trends in analgesic burden, kyphoplasty requirement, and edema resolution. The safety profile was excellent. These findings support the conduct of prospective, randomized, placebo-controlled trials to confirm BioSi-DK as an effective adjunct therapy for OVCFs.