NCT06359353CompletedPhase 4
Effect of Pitavastatin on Bone
Effect of Pitavastatin on Bone Metabolism in Patients With Hypercholesterolemia and Low Bone Mass
Source: ClinicalTrials.gov · Last updated 11 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 1 Apr 2024
- Start date
- 8 Apr 2019
- Primary completion date
- 10 Feb 2022
- Lead sponsor
- Seoul National University Bundang Hospital
- NCT number
- NCT06359353
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 70
- From 8 Apr 2019 to the primary completion date, 10 Feb 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have used a statin medication for more than one month within the last 3 months.
- Patients currently using thiazolidinediones, a class of oral antidiabetic medications.
Other illness
- Patients undergoing treatment for malignant tumors.
Other
- Patients who have used oral or injectable glucocorticoids for more than one week within the last 3 months.
Who the study is looking for
- 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.
Age in the registry: - to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.