Statin and Bone Health

• Status: Enrolling by invitation
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims to evaluate the impact of simvastatin on the bone density of postmenopausal women with type 2 diabetes over a duration of 18 months, using a randomized controlled trial design. Aiming to recruit 240 patients, half of them will be randomly assigned to receive simvastatin treatment, while the other half will receive ezetimibe, also a lipid-lowering agent with no known effect on bone. Bone density will be measured at the baseline and the end of the study for comparison of the changes between the simvastatin and the ezetimibe groups.

This is an investigator-initiated study. The principal investigator and the study team will be responsible for ensuring that the study is conducted in compliance with this protocol and the study data collected are verified against the relevant source documents.

All participants will undergo clinical and biochemical assessments at baseline of the trial. Participants will be seen by an endocrinologist at baseline and subsequent follow-up visits at 3, 6, 12 and 18 months respectively.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Ezetimibe; Simvastatin

Criteria

Inclusion Criteria:

• Chinese women

• Aged 50 to 74 years (inclusive);

• Type 2 diabetes Mellitus;

• Postmenopausal: confirmed with the last menstrual period >12 months by the time of recruitment into the study

Exclusion Criteria:

• Entry HbA1c >8.5%;

• On thiazolidinedione;

• Baseline LDL-cholesterol >3.0 mmol/L, triglyceride >5.0 mmol/L, or known familial hypercholesterolaemia;

• History of hip and/or clinical vertebral fractures;

• Osteoporosis by BMD criteria on DXA;

• On anti-osteoporosis therapy within the prior 2 years;

• Evidence of secondary causes of osteoporosis including Cushing's syndrome, acromegaly, thyrotoxicosis, primary hyperparathyroidism, metabolic bone diseases (e.g. osteomalacia), and systemic glucocorticoid treatment;

• Evidence of documented ASCVD, which includes previous acute coronary syndrome, stable angina, coronary revascularization, stroke and transient ischaemic attack and peripheral arterial disease;

• On lipid-lowering therapy within the prior 2 years;

• Known contraindications to statin therapy including allergy, intolerance and significant liver function abnormality (alanine aminotransferase level >3 times upper limit of normal);

• Significant diabetic complication(s): pre-proliferative / proliferative diabetic retinopathy, diabetic maculopathy, overt proteinuria, estimated glomerular filtration rate (eGFR) <30 mL/min;

• Inability to give an informed consent