Effect of Pitavastatin on Bone

Phase 4

Completed

• Conditions: Osteoporosis, Osteopenia; Hypercholesterolemia; Menopausal Osteoporosis
• Interventions: Drug: Pitavastatin

• Registration Number: NCT06359353
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-08
• Primary Completion: 2022-02-10
• Study Completion: 2023-12-19
• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of