Effect of Pitavastatin on Bone

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06359353
• Other study ID #: B-1902-520-004
• Status: Completed
• Phase: Phase 4
• Start date: April 8, 2019
• Est. completion date: December 19, 2023

Study information

• Verified date: April 2024
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 19, 2023
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Hypercholesterolemia
• Menopausal Osteoporosis
• Osteoporosis
• Osteoporosis, Osteopenia
• Osteoporosis, Postmenopausal

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of the outcomes after 12 months	bone mineral density and bone metabolism markers	24 months, up to 36 months
Primary	Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months	nmol BCE/L	6 month
Secondary	Change in blood C-Telopeptide of Type I Collagen levels	ng/L	6 and 12 months
Secondary	Change in blood Osteocalcin levels	ng/mL	6 and 12 months
Secondary	Change in urinary N-Telopeptide of Type I Collagen levels	nmol BCE/L	6 and 12 months
Secondary	Change in blood Procollagen Type 1 N-Terminal Propeptide levels	ng/mL	6 and 12 months
Secondary	Change in blood LDL-cholesterol levels	mg/dL	6 and 12 months
Secondary	Change in blood HbA1c levels		6 and 12 months
Secondary	Changes in bone mineral density	measured by dual-energy X-ray absorptiometry	12 months