The effects of statin therapy on the osteoprotegerin-RANKL system, correlation with vascular disease and bone metabolism in patients with Type 2 diabetes.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004368-34-IE

Enrollment

Registered

2008-06-04

Start date

2008-08-18

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We hope to elucidate whether statins affect levels of serum OPG in Type 2 Diabetic patients, and if they have any effect on indices of arterial stiffness. Furthermore, statins have been shown to increase bone mineral density, and we wish to investigate this with regards to patients with diabetes by observing their effect on markers of bone turnover and by performing DXA scans. MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Trade Name: Lipitor 10mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ATORVASTATIN CAS Number: 134523005 Concentration unit: mg milligram(s) Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age > 40 years Type 2 diabetes HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age 10mg atorvastatin, 40mg pravastatin, or 20mg simvastatin Type 1 diabetes mellitus Women of child bearing potential Pregnant women Renal dysfunction, defined as a creatinine greater than 150µmol/l History of or current malignancy Treatment with agents known to interfere with OPG/RANKL system such as bisphosphonates, vitamin D, strontium Recent (3 months) change in diabetes treatment Recent vertebral or non-vertebral fracture in the last 6 months Recent (within last 6 months) cardiovascular or cerebrovascular event Recent (within last 6 months) coronary angioplasty Children/Minors (<18 years of age) Unable to read or give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of statin therapy on OPG/RANKL levels in patients with type 2 diabetes.;Secondary Objective: To assess whether statin therapy reduces arterial stiffness in patients with type 2 diabetes. To establish the effect of statins on bone metabolism in patients with type 2 diabetes.;Primary end point(s): Primary endpoint: Serum sample for OPG and RANKL Serum sample for TRAIL (TNF-related apoptosis-inducing ligand) Pulse-wave velocity Body mass index Waist circumference Glycosylated haemoglobin Fasting plasma glucose Fasting lipid profile Fasting insulin and C-peptide for calculation of HOMA analysis Serum sample for Bone Alkaline Phosphatase, P1NP and C-TX, PTH and Vit D DXA scan for bone-mineral density	—

Measure

Time frame

Main Objective: To investigate the effect of statin therapy on OPG/RANKL levels in patients with type 2 diabetes.;Secondary Objective: To assess whether statin therapy reduces arterial stiffness in patients with type 2 diabetes. To establish the effect of statins on bone metabolism in patients with type 2 diabetes.;Primary end point(s): Primary endpoint: Serum sample for OPG and RANKL Serum sample for TRAIL (TNF-related apoptosis-inducing ligand) Pulse-wave velocity Body mass index Waist circumference Glycosylated haemoglobin Fasting plasma glucose Fasting lipid profile Fasting insulin and C-peptide for calculation of HOMA analysis Serum sample for Bone Alkaline Phosphatase, P1NP and C-TX, PTH and Vit D DXA scan for bone-mineral density

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Countries

Ireland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026