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Effect of Pitavastatin on Bone

NCT06359353 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-04-11

No results posted yet for this study

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

Interventions

DRUG

Pitavastatin

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

Sponsors & Collaborators

  • JW Pharmaceutical

    collaborator INDUSTRY

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Soo Soo, M.D. Ph.D. · Seoul National University Bundang Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-08
Primary Completion
2022-02-10
Completion
2023-12-19

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06359353 on ClinicalTrials.gov