Effect of Simvastatin on Bone Metabolism and Arterial Calcification Metabolism: A Sodium Fluoride PET CT Imaging Study

Withdrawn

• Conditions: osteopenia; Botontkalking (osteoporose); arteriosclerosis; atherosclerosis; osteoporosis; 10011082; 10003216

• Registration Number: NL-OMON38994
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the absolute change in fluorine-18 metabolism in the<br /><br>2nd, 3rd, and 4th lumbar vertebral body (quantified by the volumetric bone<br /><br>metabolic rate; bodyweight corrected standardized uptake value [g/mL]<br /><br>multiplied by the volume of the vertebral body) between baseline and 3 months<br /><br>after baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Maximum standardized uptake value in the major arteries (aorta, carotid<br /><br>arteries, coronary arteries) between baseline and three months after baseline.</p><br>