NCT06359353

Effect of Pitavastatin on Bone

Effect of Pitavastatin on Bone Metabolism in Patients With Hypercholesterolemia and Low Bone Mass

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: Female
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Osteoporosis, Osteopenia
• Hypercholesterolemia
• Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Pitavastatin	Pitavastatin 2 mg or 4 mg once daily \* The dosage is determined based on cholesterol levels and the physician's decision.

Timeline

• Start date: 2019-04-08
• Primary completion: 2022-02-10
• Completion: 2023-12-19
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: South Korea