Effects of cocoa extract supplementation and multivitamin/multimineral supplements on self-reported fractures in the Cocoa Supplement and Multivitamins Outcomes Study randomized clinical trial
Authors' conclusion
These findings do not support the use of cocoa extract or MVM to decrease fracture risk in older individuals not selected for pre-existing osteoporosis.
Study context
- Population
- COSMOS participants: females aged ≥65 yr and males aged ≥60 yr, not selected for pre-existing osteoporosis
- Participants
- 21,442 participants
- Comparison
- Cocoa extract vs placebo; MVM vs placebo
- Primary endpoint
- Total clinical fracture (hip, upper leg, forearm/wrist, pelvis, upper arm/shoulder, spine, knee, or other), hip fracture, and nonvertebral fracture (self-reported)
- Follow-up
- Median intervention 3.6 (IQR 3.2-4.2) yr
Methodological details2 × 2 factorial, placebo-controlled
- 2 × 2 factorial
- Placebo-controlled
Primary result
As reported in the abstract
Incident fractures
Adjusted hazard ratio (95% CI)
Cocoa extractvs Placebototal clinical fracture
1.03(0.95–1.12)
Cocoa extractvs Placebononvertebral fracture
1.05(0.96–1.14)
MVMvs Placebototal clinical fracture
1.09(1.00–1.19)
MVMvs Placebohip fracture
1.06(0.80–1.42)
MVMvs Placebononvertebral fracture
1.10(1.00–1.20)
- Incident clinical fractures during intervention
- 2083
Original publication
Effects of cocoa extract supplementation and multivitamin/multimineral supplements on self-reported fractures in the Cocoa Supplement and Multivitamins Outcomes Study randomized clinical trial. J Bone Miner Res. Published 18 February 2025. doi:10. 1093/ jbmr/ zjaf030
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