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Trial Outcomes & Findings for Effect of Atorvastatin on Bone-vascular Axis (NCT NCT02342015)

NCT ID: NCT02342015

Last Updated: 2021-05-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

3 months

Results posted on

2021-05-20

Participant Flow

Participant milestones

Participant milestones
Measure
Atorvastatin
Atorvastatin 40 mg/day for three months Atorvastatin: Atorvastatin 40mg/day for three months
Overall Study
STARTED
20
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Atorvastatin
n=20 Participants
Atorvastatin 40 mg/day for three months
Age, Continuous
64 years
STANDARD_DEVIATION 5.3 • n=20 Participants
Sex: Female, Male
Female
20 Participants
n=20 Participants
Sex: Female, Male
Male
0 Participants
n=20 Participants
Region of Enrollment
Italy
20 participants
n=20 Participants
Total Cholesterol
257.7 mg/dl
STANDARD_DEVIATION 24.1 • n=20 Participants
high-sensitivity C-reactive protein (hs-CRP)
1 mg/dl
n=20 Participants
Osteocalcin (OCN)
25.4 ng/ml
STANDARD_DEVIATION 5.7 • n=20 Participants
Bone Alkaline Phosphatase (BAP)
14.5 mcg/L
STANDARD_DEVIATION 2.5 • n=20 Participants
Osteoprotegerin (OPG)
644.5 pg/ml
STANDARD_DEVIATION 271.8 • n=20 Participants
cross-linked carboxy-terminal telopeptide of type I collagen-I (CTX-I)
529.3 ng/ml
STANDARD_DEVIATION 178.6 • n=20 Participants
Calcium
2.36 mmol/L
STANDARD_DEVIATION 0.06 • n=20 Participants
Phosphorus
1.13 mmol/L
STANDARD_DEVIATION 0.10 • n=20 Participants
Vitamin D3
74.8 nmol/L
STANDARD_DEVIATION 45.9 • n=20 Participants
CD34+/BAP+ cells
136.1 cells/million events
STANDARD_DEVIATION 28.9 • n=20 Participants
CD34+/OCN+ cells
200.9 cells/million events
STANDARD_DEVIATION 40.8 • n=20 Participants
OCN+/BAP+ cells
11180.2 cells/million events
STANDARD_DEVIATION 3657.3 • n=20 Participants
CD34+/OCN+/BAP+ cells
123.6 cells/million events
STANDARD_DEVIATION 29.5 • n=20 Participants

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure
Atorvastatin
n=20 Participants
Atorvastatin 40 mg/day for three months
Relative Change in OPG/RANK/RANKL mRNA Expression in Isolated T Cells and Monocytes
0.76 relative fold change
Standard Error 0.1

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure
Atorvastatin
n=20 Participants
Atorvastatin 40 mg/day for three months
Change in Circulating Levels of Osteoprogenitor Cells (CD34+/OCN+/BAP+ Cells)
59.1 cells/million events
Standard Deviation 13.6

Adverse Events

Atorvastatin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marcello Rattazzi

University of Padova

Phone: +300498211867

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place