Effect of Pitavastatin on Bone

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

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 Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Osteoporosis, Osteopenia; Menopausal Osteoporosis
• Intervention / Treatment: Drug: Pitavastatin

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pitavastatin; Pitavastatin 2 mg or 4 mg once daily * The dosage is determined based on cholesterol levels and the physician's decision.	Drug: Pitavastatin; Pitavastatin 2 mg or 4 mg once daily * The dosage is determined based on cholesterol levels and the physician's decision.; Other Names: Livalo tab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months	nmol BCE/L	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood C-Telopeptide of Type I Collagen levels	ng/L	6 and 12 months
Change in blood Osteocalcin levels	ng/mL	6 and 12 months
Change in urinary N-Telopeptide of Type I Collagen levels	nmol BCE/L	6 and 12 months
Change in blood Procollagen Type 1 N-Terminal Propeptide levels	ng/mL	6 and 12 months
Change in blood LDL-cholesterol levels	mg/dL	6 and 12 months
Change in blood HbA1c levels		6 and 12 months
Changes in bone mineral density	measured by dual-energy X-ray absorptiometry	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of the outcomes after 12 months	bone mineral density and bone metabolism markers	24 months, up to 36 months

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: JW Pharmaceutical
• Investigators: Principal Investigator: Soo Soo, M.D. Ph.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pitavastatin
• Other Study ID Numbers: B-1902-520-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No