Phase 4 N=20 Basic Science

Effect of Atorvastatin on Bone-vascular Axis

Osteoporosis · Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT02342015 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Relative Change in OPG/RANK/RANKL mRNA Expression in Isolated T Cells and Monocytes — 0.76 relative fold change — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Atorvastatin (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: University of Padova
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Relative Change in OPG/RANK/RANKL mRNA Expression in Isolated T Cells and Monocytes	0.76	<0.05 sig
PRIMARY Change in Circulating Levels of Osteoprogenitor Cells (CD34+/OCN+/BAP+ Cells)	59.1	<0.05 sig

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02342015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.