Statin and Bone Health

NCT05613400 | Unknown Phase 4

• 1 other identifier: STATIN001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Bone Density; Simvastatin

Outcome Measures

Primary Outcomes (1)

• The change in the TH BMD after 18 months of simvastatin compared with ezetimibe

  BMD at the TH will be measured with DXA and compared.

  Screening visit and Visit 5 (18 month after baseline visit)

Secondary Outcomes (6)

• The changes in the LS BMD after 18 months of simvastatin compared with ezetimibe

  Screening visit and Visit 5 (18 month after baseline visit)

• The changes in the FN BMD after 18 months of simvastatin compared with ezetimibe

  Screening visit and Visit 5 (18 month after baseline visit)

• The changes in BMD over distal radius after 18 months of simvastatin compared with ezetimibe

  Screening visit and Visit 5 (18 month after baseline visit)

• The changes in bone turnover marker, carboxy-terminal cross-linked telopeptide of type 1 collagen (CTX) after 6 months and 18 months of simvastatin compared with ezetimibe

  Baseline visit, Visit 3 (6 months after Baseline visit) and Visit 5 (18 months after Baseline visit)

• The changes in bone turnover marker, amino-terminal propeptides of type 1 collagen (P1NP) after 6 months and 18 months of simvastatin compared with ezetimibe

  Baseline visit, Visit 3 (6 months after Baseline visit) and Visit 5 (18 months after Baseline visit)

Study Arms (2)

Simvastatin 10mg/day

EXPERIMENTAL

One simvastatin 10mg-tablet and one placebo tablet with the shape of ezetimibe 10mg each day.

Drug: Simvastatin 10mg

Ezetimibe 10mg/day

ACTIVE COMPARATOR

One ezetimibe 10mg-tablet and one placebo tablet with the shape of simvastatin 10mg each day.

Drug: Ezetimibe 10mg

Interventions

Simvastatin 10mg DRUG

One simvastatin 10mg-tablet

Simvastatin 10mg/day

Ezetimibe 10mg DRUG

One ezetimibe 10mg-tablet

Ezetimibe 10mg/day

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Diabetes Centre, 2/F, Block L, Department of Medicine, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (28)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Simvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tak Wai David Lui, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The computer-generated sequence will be supplied by the study statistician, independent of the investigators. To facilitate double-blinding, placebo tablets with the same shapes as simvastatin 10mg and ezetimibe 10mg, respectively.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Eligible participants will be randomly allocated 1:1 to 18 months of simvastatin 10mg/day or ezetimibe 10mg/day.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: April 13, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)