Effect of Pitavastatin on Bone
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
70 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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