osteoporose, fracturen fragile bones osteoporosis
Conditions
Interventions
Double-blind, placebo-controlled trial, with block randomisation of subjects of
70 years and older to one of the two treatments for at least two years:
- 500 µg vitamin B12 and 0.4 mg folic acid in o
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age: 70 years and older; based on entry date into study tHcy: Fasting plasma Hcy level > 15 µmol/L and 85% (during run-in period)
Exclusion criteria
Exclusion criteria: Vitamin use: No current or recent (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture incidence is the primary outcome measure. Time to fracture is also included in this outcome measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood: tHcy, folate, vitamin B12, MMA, vitamin D, bone turnover markers, markers of endothelial function, markers of low-grade inflammation, markers of the vascular NO system, and brain natriuretic peptide which is a novel marker of chronic heart failure, DNA-methylation and uracil misincorporation. Other: Height, weight, heel ultrasound (BUA and SOS), bone mineral density, physical performance, physical activity, medicine and supplement use, cognitive functioning, dietary assessment, MNA and SNAQ, hand grip strength and quality of Life | — |
Countries
Netherlands
Outcome results
None listed