Phase 4
Completed N=20
Effect of Atorvastatin on Bone-vascular Axis
Source: ClinicalTrials.gov NCT02342015 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Relative Change in OPG/RANK/RANKL mRNA Expression in Isolated T Cells and Monocytes — 0.76 relative fold change — p=<0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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)
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. Informational only — not medical advice.