CompletedNCT06359353Updated Apr 11, 2024

Effect of Pitavastatin on Bone

A Phase 4 interventional study of Pitavastatin in Osteoporosis, Osteopenia, Hypercholesterolemia and Menopausal Osteoporosis, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in South Korea. Open to female participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Seoul National University Bundang Hospital · Phase 4, Interventional, and Prevention

From the registry’s dates

Registered 4 years 11 months after the study started (first participant enrolled Apr 2019, registered Apr 2024).

Phase: Phase 4
Study type: Interventional
Enrollment: 70
Allocation: Not applicable
Ages: Up to 75 Years
Sex: Female

Study 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.

Conditions studied

Osteoporosis, Osteopenia
Hypercholesterolemia
Menopausal Osteoporosis

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In context

Osteoporosis

1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.

This study's enrollment of 70 is below the median of 95 across 1,152 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 75 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 70 participants (actual)

Study arms

Experimental
Pitavastatin
Pitavastatin 2 mg or 4 mg once daily \* The dosage is determined based on cholesterol levels and the physician's decision.
Drug: Pitavastatin

Interventions

DrugPitavastatin
Pitavastatin 2 mg or 4 mg once daily \* The dosage is determined based on cholesterol levels and the physician's decision.
Also known as: Livalo tab

What researchers measure

Primary outcomes

Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months
nmol BCE/L
Time frame: 6 month

Secondary outcomes

Change in blood C-Telopeptide of Type I Collagen levels
ng/L
Time frame: 6 and 12 months
Change in blood Osteocalcin levels
ng/mL
Time frame: 6 and 12 months
Change in urinary N-Telopeptide of Type I Collagen levels
nmol BCE/L
Time frame: 6 and 12 months
Change in blood Procollagen Type 1 N-Terminal Propeptide levels
ng/mL
Time frame: 6 and 12 months
Change in blood LDL-cholesterol levels
mg/dL
Time frame: 6 and 12 months
Change in blood HbA1c levels
Time frame: 6 and 12 months
Changes in bone mineral density
measured by dual-energy X-ray absorptiometry
Time frame: 12 months

Other outcomes

Changes of the outcomes after 12 months
bone mineral density and bone metabolism markers
Time frame: 24 months, up to 36 months

Study locations

1 site

Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 463-707, South Korea

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Feb 2022, 34 months.

Of 56 non-industry phase 4 interventional studies under Osteoporosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's 34 months is below that.

Counting every sponsor, half of 64 studies reached it within 46 months; a quarter within 24 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 1, 2024
First posted: Apr 11, 2024
StartActual: Apr 8, 2019
Primary completionActual: Feb 10, 2022
CompletionActual: Dec 19, 2023
Last update: Apr 11, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06359353
Lead sponsor: Seoul National University Bundang Hospital
Collaborators: JW Pharmaceutical
Responsible party: Soo Lim (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted: Apr 11, 2024
Start date: Apr 8, 2019
Primary completion: Feb 10, 2022
Completion: Dec 19, 2023
Last update: Apr 11, 2024

Study contacts

Soo Soo, M.D. Ph.D.

principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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