Effect of Atorvastatin on Bone-vascular Axis

NCT02342015 | Completed Phase 4 Results

• 1 other identifier: Studio clinico n° 14/AULSS 9
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoporosis; Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• Relative Change in OPG/RANK/RANKL mRNA Expression in Isolated T Cells and Monocytes

  Isolated T cells and monocytes will be obtained at baseline and at the end of the treatment period. Gene expression analysis will be performed in each cell type to assess the expression level of OPG, RANK, and RANKL at baseline and after three months of treatment.

  3 months

• Change in Circulating Levels of Osteoprogenitor Cells (CD34+/OCN+/BAP+ Cells)

  Circulating levels of osteoprogenitor cells (CD34+/OCN+/BAP+ cells) will be measured by FACS analysis in each patient at baseline and after three months of treatment with Atorvastatin.

  3 months

Study Arms (1)

Atorvastatin

EXPERIMENTAL

Atorvastatin 40 mg/day for three months

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

Atorvastatin 40mg/day for three months

Also known as: Lipitor

Atorvastatin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed osteoporosis (T score ≤ -2.5 SD at either the lumbar spine or femoral neck)
• LDL-cholesterol ≥ 130 mg/dl

You may not qualify if:

• History of bone fractures,
• Clinical evidence of atherosclerotic disease
• CKD (stage III-V),
• Liver disease
• COPD
• Rheumatic disorders;
• Current or previous treatment with statins, steroids, hormonal replacement therapies, and antiosteoporotic drugs (including vitamin D and calcium supplementation)

Sponsors & Collaborators

• University of Padova: lead

MeSH Terms

Conditions

Osteoporosis; Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Marcello Rattazzi
• Organization: University of Padova

marcello.rattazzi@unipd.it

+300498211867

Study Officials

• Marcello Rattazzi, MD

  University of Padova, Department of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: January 19, 2015
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 20, 2021
• Results First Posted: May 20, 2021

Record last verified: 2021-04