Using probiotic supplementation to support bone health in postmenopausal women: a randomized, double-blind, parallel, placebo-controlled, multi-center study.

Studies using rodent models have demonstrated the ability for probiotics to attenuate estrogen-related bone loss, but findings in humans are limited. Postmenopausal women consuming a novel combination of bacteria strains as a probiotic supplement demonstrated no changes in bone health outcomes. PURPOSE: This study determined if a probiotic supplement could attenuate the loss of femoral neck bone mineral density (BMD) and assessed its effect on fracture risk and markers of bone cell activity. METHODS: Seventy-two postmenopausal women (40-59 years) were randomized to a daily probiotic supplement or placebo for 48 weeks. Femoral neck BMD was assessed at weeks 0 and 48 using DXA along with fracture risk using the FRAX® assessment tool. Serum procollagen type 1 N-terminal propeptide (P1NP), bone-specific alkaline phosphatase (BALP), cross-linked C-telopeptide of type I collagen (CTx), and osteocalcin (OC) were analyzed at weeks 0, 12, 24, and 48. RESULTS: There was no significant time by treatment interaction (p > 0.05) for femoral neck BMD or fracture risk. Independent of treatment, femoral neck BMD decreased (p = 0.034), while risk of hip (p = 0.003) and major osteoporotic fracture (p = 0.044) increased. There was no mean difference in bone marker levels between groups from baseline to endpoint. These findings align with the lack of difference in BMD and fracture risk at the end of study. CONCLUSION: Probiotics did not alter BMD or fracture risk, as supported by bone cellular activity that was similar to the placebo group by the end of study.