Clinical trial NCT06359353: Effect of Pitavastatin on Bone
Official title: Effect of Pitavastatin on Bone Metabolism in Patients With Hypercholesterolemia and Low Bone Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis, Osteopenia
Hypercholesterolemia
Menopausal Osteoporosis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: JW Pharmaceutical
First posted: 2024-04-11
Enrollment: 70
Sex: FEMALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months
timeFrame: 6 month
Secondary outcomes:
measure: Change in blood C-Telopeptide of Type I Collagen levels
timeFrame: 6 and 12 months
measure: Change in blood Osteocalcin levels
timeFrame: 6 and 12 months
measure: Change in urinary N-Telopeptide of Type I Collagen levels
timeFrame: 6 and 12 months
measure: Change in blood Procollagen Type 1 N-Terminal Propeptide levels
timeFrame: 6 and 12 months
measure: Change in blood LDL-cholesterol levels
timeFrame: 6 and 12 months
measure: Change in blood HbA1c levels
timeFrame: 6 and 12 months
measure: Changes in bone mineral density
timeFrame: 12 months
Other outcomes:
measure: Changes of the outcomes after 12 months
timeFrame: 24 months, up to 36 months
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Soo, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: