Osteoporosis in hypercholesterolemic patients MedDRA version: 9.1 Level: LLT Classification code 10031282 Term: Osteoporosis
Conditions
Interventions
Trade Name: TORVAST
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Atorvastatin
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: .04-
Sponsors
U.L.S.S. 9 DI TREVISO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female patients with osteoporosis (T score 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed