Hypercholesterolemia, Menopausal Osteoporosis, Osteoporosis, Osteopenia
Conditions
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.
Interventions
DRUGPitavastatin
Pitavastatin 2 mg or 4 mg once daily \* The dosage is determined based on cholesterol levels and the physician's decision.
Sponsors
JW Pharmaceutical
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months | 6 month | nmol BCE/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| Change in blood Procollagen Type 1 N-Terminal Propeptide levels | 6 and 12 months | ng/mL |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes of the outcomes after 12 months | 24 months, up to 36 months | bone mineral density and bone metabolism markers |
Countries
South Korea
Outcome results
None listed