NCT06359353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

April 1, 2024

Last Update Submit

April 5, 2024

Conditions

Osteoporosis, OsteopeniaHypercholesterolemiaMenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months

    nmol BCE/L

    6 month

Secondary Outcomes (7)

  • Change in blood C-Telopeptide of Type I Collagen levels

    6 and 12 months

  • Change in blood Osteocalcin levels

    6 and 12 months

  • Change in urinary N-Telopeptide of Type I Collagen levels

    6 and 12 months

  • Change in blood Procollagen Type 1 N-Terminal Propeptide levels

    6 and 12 months

  • Change in blood LDL-cholesterol levels

    6 and 12 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Changes of the outcomes after 12 months

    24 months, up to 36 months

Study Arms (1)

Pitavastatin

EXPERIMENTAL

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

Drug: Pitavastatin

Interventions

PitavastatinDRUG

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

Also known as: Livalo tab
Pitavastatin

Eligibility Criteria

AgeUp to 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

OsteoporosisBone Diseases, MetabolicHypercholesterolemiaOsteoporosis, Postmenopausal

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Soo Soo, M.D. Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2024

First Posted

April 11, 2024

Study Start

April 8, 2019

Primary Completion

February 10, 2022

Study Completion

December 19, 2023

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations

KR(1)