Effects of Lactobacillus reuteri on Bone in Older Women” (ELBOW)
Performed at a geriatric medical unit
Inclusion criteria: Women with a T-score ≤-1 standard deviation (SD) for bone mineral density (BMD) at the spine, hip or femoral neck measured by DXA
Exclusion criteria: Osteoporosis (T-score <-2.5 at the spine or the total hip) | Untreated hyperthyroidism | Rheumatoid arthritis | COPD, IBD | celiac disease | Diabetes | Malignancy |Oral glucocorticoids or antibiotics
Patients were randomized to receive either
Freeze-dried L. reuteri (1010 colony-forming units of bacteria)
Relative change after 12 months of tibia total volumetric BMD (vBMD), a measurement that indicates early bone changes
Areal BMD (aBMD) measured at the hip and spine | trabecular bone volume fraction | Cortical vBMD | Cortical thickness | Serum markers for bone turnover and inflammation | Serum HbA1c | Body composition
30 in each arm required for a statistical power of 80%
90 women were included and 70 women completed the study
Age of participants
Exposed (n=35): 76.4±1.0 years
Placebo (n=35): 76.3±1.1 years
Compared to placebo, L. reuteri reduced loss of total vBMD
Intention-to-treat analysis (n=90): Bone loss in L. reuteri group (‐0.83%) was ½ that of placebo (‐1.85%) with mean difference 1.02%; p=0.047
Protocol analysis (n=70): Bone loss in L. reuteri group (‐0.93%) was similarly reduced compared to placebo (‐1.86%) with mean difference 0.93%; p=0.013
Similar but smaller effects were observed in the secondary bone variable outcomes, but these did not reach significance
Adverse events did not differ between groups
Probiotic supplementation with L. reuteri for 12 months reduced bone loss in older women with BMD
More research is required
Impact on secondary outcomes (study not sufficiently powered)
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