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),…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 38 participants or records.
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