Efficacy and safety of pitavastatin on bone metabolism in patients with hypercholesterolemia and low bone mass

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004114

Enrollment

Registered

2019-07-02

Start date

2019-07-15

Completion date

Unknown

Last updated

2019-07-17

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

Conditions

None listed

Interventions

Drug : This is a single-arm, open label study. Study participant will be assigned either pitavastatin 2 mg or pitavastatin 4 mg based on their LDL-cholesterol levels (LDL 130).

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: - <70 years-old menopausal females - T-score: -1.5 ~ - 3.0 - Dyslipidemia - C-telopeptide > 0.4 ng/mL or NTX > 16.5 nmolBCE/L

Exclusion criteria

Exclusion criteria: - statin medication within 3 months - glucocorticoid injection more than 1 week within 3 months - use of thiazolidinedione or SGLT2-inhibitor - malignancy under active treatment

Design outcomes

Primary

Measure	Time frame
Change in C-telopeptide levels from baseline	—

Secondary

Measure	Time frame
Change in C-telopeptide levels from baseline;Change in LDL-cholesterol levels from baseline;Change in LDL-cholesterol levels from baseline;Change in HbA1c levels from baseline;Change in osteocalcin levels from baseline;Change in NTX levels from baseline	—

Countries

Korea, Republic of

Contacts

Public ContactJaeEun KIM

Seoul National University Bundang Hospital

jjaen2@snubh.org+82-31-787-8823

Outcome results