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Lactobacillus reuteri Reduces Bone Loss in Osteopenia

10/2/2018 2:50:54 PM
Osteoporosis-related fractures affect as many as half of all women and a quarter of all men over the age of 50. Bisphosphonate medications have been shown to reduce fracture risk, but their use is limited by fears of side effects and a recommended duration of use no longer than 3-5 years. Safer options that can be taken for more extended periods of time are needed to reduce bone loss and fracture risk in older adults.
Modulating the gut microbiome with diet and supplementation might play a role in reducing the risk of conditions like obesity, diabetes, and autoimmune diseases. Studies in mice suggest that the microbiome may also influence bone metabolism and osteoclast formation. Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475) is a microbe that is indigenous to the human digestive tract and has been shown to prevent bone loss in mice. To evaluate whether this probiotic might also reduce bone loss in humans, researchers conducted a randomized, double-blind, placebo-controlled trial.
Participants were Swedish women between the ages of 75 and 80 years old, with bone mineral density indicating osteopenia but not osteoporosis (T scores between -2.5 and -1.0). Participants were randomized to take a placebo or freeze-dried L. reuteri 6475 (BioGaia AB, Stockholm, Sweden) at a daily dosage of 1 x 1010 CFU/day for 12 months. The primary outcome measure was relative change after 12 months in tibia total volume bone mineral density (vBMD). This outcome was chosen because the tibia is rich in trabecular bone, which has a higher turnover than cortical bone, allowing for early detection of response to interventions.
Although 90 women enrolled in the study, only 70 completed it. The most common reason for dropping out was adverse events, particularly gastrointestinal symptoms. Results were calculated for all randomized subjects (intention-to-treat, or ITT) and for those who completed the study (per-protocol, or PP).
The mean relative change in the tibia total vBMD after 12 months in the ITT population was -0.83% in the L. reuteri 6475 group and -1.85% in the placebo group, with a mean difference between groups of 1.02% (p=.047). Results were similar for the PP population, with a mean change of -0.93% in the L. reuteri 6475 group and -1.86% in the placebo group (p=.013). None of the secondary outcomes that aimed to detect associated mechanisms (e.g., serum markers for bone turnover, serum markers for inflammation, and serum HbA1c) reached statistical significance in either the ITT or PP populations.
These results suggest that L. reuteri 6475 reduces bone loss in older women with low bone density, such that those taking the probiotic experience about half as much bone loss as those taking a placebo. The size of this treatment effect is not as large as the effect of bisphosphonates, and the associated risk of fracture was not evaluated. Despite these study weaknesses, the results presented here provide a proof of concept that probiotics might be a promising new approach to protecting bone mineral density in older women. 
Nilsson AG, Sundh D, Bäckhed F, Lorentzon M. Lactobacillus reuteri reduces bone loss in older women with low bone mineral density: a randomized, placebo-controlled, double-blind, clinical trial. J Intern Med. 2018.

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