| Trial ID: | L5656 |
| Source ID: | NCT05613400
|
| Associated Drug: |
Simvastatin 10mg
|
| Title: |
Statin and Bone Health
|
| Acronym: |
|
| Status: |
ENROLLING_BY_INVITATION
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Simvastatin 10mg|DRUG: Ezetimibe 10mg
|
| Outcome Measures: |
Primary: 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: The changes in the LS BMD after 18 months of simvastatin compared with ezetimibe, BMD at the LS will be measured with DXA and compared., Screening visit and Visit 5 (18 month after baseline visit)|The changes in the FN BMD after 18 months of simvastatin compared with ezetimibe, BMD at the FN will be measured with DXA and compared., 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, BMD at the distal radius will be measured with DXA and compared., 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)|The changes in TBS after 18 months of simvastatin compared with ezetimibe, A higher TBS indicates better quality of bone which is less likely to fracture. The minimum value of TBS is 0.8, while the maximum value of TBS is 1.6., Screening visit and Visit 5 (18 month after baseline visit)
|
| Sponsor/Collaborators: |
Sponsor: The University of Hong Kong
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
240
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
|
| Start Date: |
2022-04-13
|
| Completion Date: |
2025-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2022-11-28
|
| Locations: |
Diabetes Centre, 2/F, Block L, Department of Medicine, Queen Mary Hospital, Hong Kong, Hong Kong
|
| URL: |
https://clinicaltrials.gov/show/NCT05613400
|
