Effect of Pitavastatin on Bone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-08

Study Completion Date

2023-12-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Atorvastatin on Bone-vascular Axis

NCT02342015

Osteoporosis Hypercholesterolemia

COMPLETED PHASE4

Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

NCT01753856

Osteoporosis

COMPLETED PHASE4

Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

NCT00532337

Osteoporosis Osteopenia

COMPLETED PHASE2

A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

NCT01457950

Osteoporosis, Postmenopausal

COMPLETED PHASE3

Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

NCT00729651

Osteoporosis Postmenopausal

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis, Osteopenia Hypercholesterolemia Menopausal Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pitavastatin

Pitavastatin 2 mg or 4 mg once daily

\* The dosage is determined based on cholesterol levels and the physician's decision.

Group Type EXPERIMENTAL

Pitavastatin

Intervention Type DRUG

Pitavastatin 2 mg or 4 mg once daily

\* The dosage is determined based on cholesterol levels and the physician's decision.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pitavastatin

Pitavastatin 2 mg or 4 mg once daily

\* The dosage is determined based on cholesterol levels and the physician's decision.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Livalo tab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No