Limosilactobacillus reuteri 6475 and Prevention of Early Postmenopausal Bone Loss: A Randomized Clinical Trial
Authors' conclusion
In this randomized clinical trial of 239 early postmenopausal women, supplementation with L reuteri had no effect on bone loss or bone turnover over 2 years. The observed interaction between BMI and treatment effect warrants further investigation.
Study context
- Population
- Early postmenopausal women aged 50 to 60 years, single centre in Gothenburg, Sweden; median age 55 (IQR 53–56) years
- Participants
- 239 women
- Comparison
- L reuteri (low or high dose) twice daily vs placebo; all capsules with cholecalciferol 200 IU
- Primary endpoint
- Relative change in tibia total vBMD
- Follow-up
- 2 years
Methodological detailsdouble-blind, placebo-controlled, single-centre
- Double-blind
- Placebo-controlled
- Single-centre
Primary result
As reported in the abstract
Percent change in tibia total vBMD
Least-squares means
−0.08
95 CI −0.85 to 0.69
High dose
Least-squares means
−0.22
95% CI −0.99 to 0.55
Low dose
Secondary outcomes
Hip and spine volumetric bone mineral density (vBMD), tibia cortical area and BMD · 2 years
- Decreased significantly in all groups, with no group-to-group differences
Other predefined outcomes
- No significant treatment effects on any other predefined outcomes
Body mass index (BMI) × treatment interaction (prespecified sensitivity analysis) · 2 years
- Significant interaction between BMI and treatment effect
Safety
- No significant adverse effects were observed
Original publication
Limosilactobacillus reuteri 6475 and Prevention of Early Postmenopausal Bone Loss: A Randomized Clinical Trial. JAMA Netw Open. Published 3 June 2024. doi:10.
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