The OPG/RANKL/RANK system: implication for osteoporosis and atherosclerosis development. Potential role of the treatment with Atorvastatin - ND

Conditions: Osteoporosis in hypercholesterolemic patients
MedDRA version: 9.1Level: LLTClassification code 10031282Term: Osteoporosis

Registration Number: EUCTR2007-005618-38-IT

Lead Sponsor: .L.S.S. 9 DI TREVISO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Female patients with osteoporosis (T score < -2.5) and Total plasma cholesterol >220 mg/dl;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients taking hypolipidemic drugs, bisphosphonates, estrogens, raloxifene, glucorticoids; - Evidence of inflammatory or endocrine disorders, chronic renal failure, malabsorption. - Patients taking drugs that interfere with metabolism of statin by CYP3A4 (such as cyclosporin, niacin, fibrates, erythromycin and antifungal drugs)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish if a short-term (3 months) treatment with statins leads to changes in OPG/RANKL/RANK expression by pheripheral blood monuclear cells (PBMC) in osteoporotic hypercholesterolemic patients.;Secondary Objective: To investigate if modified lipids can promote activation of the OPG/RANKL/RANK system in monocites/macrophages.;Primary end point(s): OPG/RANKL/RANK expression on pheripheral blood monuclear cells

Secondary Outcome Measures