Botontkalking (osteoporose) arteriosclerosis atherosclerosis osteopenia osteoporosis
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Statin naivety; 2. Age equal to or above 50 years; 3. T-score at inclusion between -1.0 and -2.5; 4. HeartSCORE equal to or above 5% (i.e. clinical indication for Simvastatine 40 mg determined at the discretion of the treating physician). 5. Karnofsky score at inclusion equal to or higher then 90%.
Exclusion criteria
Exclusion criteria: Reduced bone mass due to drugs (i.e., steroids) or a medical condition, such as hyperthyroidism, hyperparathyroidism, renal or liver failure, multiple myeloma, etc.;Current or prior treatment with bisphosphonates, calcium-antagonists, calcium supplements with or without vitamin D, PTH-agonists, and Denosumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the absolute change in fluorine-18 metabolism in the 2nd, 3rd, and 4th lumbar vertebral body (quantified by the volumetric bone metabolic rate; bodyweight corrected standardized uptake value [g/mL] multiplied by the volume of the vertebral body) between baseline and 3 months after baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum standardized uptake value in the major arteries (aorta, carotid arteries, coronary arteries) between baseline and three months after baseline. | — |
Countries
Netherlands
Outcome results
None listed