CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Atorvastatindrug
Likely dose
Atorvastatin 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02342015
NCT02342015Phase 4Completed
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Effect of Atorvastatin on OPG/RANK/RANKL Expression in Immune Cells and Circulating Levels of Osteoprogenitor Cells

University of Padova·interventional·Posted Jan 19, 2015·Updated May 20, 2021

In Brief

A Phase 4 clinical trial evaluating Atorvastatin for Osteoporosis and Hypercholesterolemia. Completed, enrolled 20 participants.

Detailed Summary

Background: Circulating osteoprogenitors and RANKL expression in immune cells have been implicated in the pathogenesis of osteoporosis and vascular calcification. The role played by statin therapy in the bone-vascular axis is unknown. Methods: Twenty naïve post-menopausal osteoporotic hypercholesterolemic women will be treated with Atorvastatin 40 mg/day for three months. Blood samples will be collected at baseline and at the end of the treatment. Gene expression analysis will be performed to assess modification in OPG/RANK/RANKL expression in isolated T-cells and monocytes. A flow cytometry analysis will be used to study changes in the levels of circulating osteoprogenitor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Hypercholesterolemia
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 19, 2015
Enrollment StartNov 1, 2012
Primary CompletionFeb 1, 2014
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.5 years ago

Interventions

Atorvastatindrug

Atorvastatin 40mg/day for three months