Overview

Statin and Bone Health

Status:
Enrolling by invitation
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
The University of Hong Kong
Treatments:
Ezetimibe
Simvastatin