Effect of Pitavastatin on Bone

Seoul National University Bundang Hospital70 enrolled

Overview

This clinical trial investigates the effects of pitavastatin on bone health in postmenopausal women with osteopenia or osteoporosis and hypercholesterolemia. Given the high prevalence of osteoporosis in aging populations and the associated risks, even with existing treatments, this study addresses a critical gap in medical research. Statins, specifically HMG-CoA reductase inhibitors, are suggested to benefit bone metabolism by promoting bone formation and reducing resorption. However, the specific impact of pitavastatin on bone metabolism lacks clinical evidence. The study's primary goal is to determine the effects of a 12-month pitavastatin regimen on bone metabolism markers in this population. This research could significantly contribute to developing more effective osteoporosis treatments for postmenopausal women, combining bone health and cholesterol management strategies.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Osteoporosis, Osteopenia Hypercholesterolemia Menopausal Osteoporosis

Eligibility

Sex: FEMALEMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are under the age of 75 and are postmenopausal. * Individuals diagnosed with osteopenia or osteoporosis, exhibiting a T-score ranging from -3.0 to -1.5. * Patients with hypercholesterolemia starting pitavastatin for the first time. * Patients exhibiting baseline bone resorption markers, specifically C-telopeptide levels of 0.300 ng/mL or above, or NTX levels above 16.5 nmolBCE/L. Exclusion Criteria: * Patients who have used a statin medication for more than one month within the last 3 months. * Patients who have used oral or injectable glucocorticoids for more than one week within the last 3 months. * Patients currently using thiazolidinediones, a class of oral antidiabetic medications. * Patients undergoing treatment for malignant tumors.

Outcomes

Primary Outcomes

Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months

nmol BCE/L

Time frame: 6 month

Secondary Outcomes

Change in blood C-Telopeptide of Type I Collagen levels

ng/L

Time frame: 6 and 12 months

Change in blood Osteocalcin levels

ng/mL

Time frame: 6 and 12 months

Change in urinary N-Telopeptide of Type I Collagen levels

nmol BCE/L

Time frame: 6 and 12 months

Change in blood Procollagen Type 1 N-Terminal Propeptide levels

ng/mL

Time frame: 6 and 12 months

Change in blood LDL-cholesterol levels

mg/dL

Time frame: 6 and 12 months

Change in blood HbA1c levels

Time frame: 6 and 12 months

Changes in bone mineral density

measured by dual-energy X-ray absorptiometry

Time frame: 12 months

Effect of Pitavastatin on Bone

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes