Osteoporosis, OsteopeniaPhase 4NCT06359353
Effect of Pitavastatin on Bone
A Phase 4 study testing Pitavastatin in people with Osteoporosis, Osteopenia and Hypercholesterolemia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Osteoporosis, Osteopenia, Hypercholesterolemia, Menopausal Osteoporosis
- What is being tested?
- Pitavastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Apr 2019to 19 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Effect of Pitavastatin on Bone Metabolism in Patients With Hypercholesterolemia and Low Bone Mass
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.
- Being tested
- Pitavastatin
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Hypercholesterolemia, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Also called Livalo tab
Pitavastatin 2 mg or 4 mg once daily
- The dosage is determined based on cholesterol levels and the physician's decision.
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin | Experimental | Pitavastatin 2 mg or 4 mg once daily
* The dosage is determined based on cholesterol levels and the physician's decision. Receives: Drug: Pitavastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months
nmol BCE/L
Measured: 6 month
Secondary outcomes (7)
Change in blood C-Telopeptide of Type I Collagen levels
ng/L
Measured: 6 and 12 months
Change in blood Osteocalcin levels
ng/mL
Measured: 6 and 12 months
Change in urinary N-Telopeptide of Type I Collagen levels
nmol BCE/L
Measured: 6 and 12 months
Change in blood Procollagen Type 1 N-Terminal Propeptide levels
ng/mL
Measured: 6 and 12 months
Change in blood LDL-cholesterol levels
mg/dL
Measured: 6 and 12 months
Change in blood HbA1c levels
Measured: 6 and 12 months
Changes in bone mineral density
measured by dual-energy X-ray absorptiometry
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start8 Apr 2019
- Primary completion10 Feb 2022
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- JW Pharmaceutical
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Soo, M.D. Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359353
- Sponsor's protocol ID
- B-1902-520-004
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pitavastatin on Bone Metabolism in Patients With Hypercholesterolemia and Low Bone Mass
- ClinicalTrials.gov ID
- NCT06359353
- Acronym / sponsor ID
- B-1902-520-004
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- JW Pharmaceutical
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin | Experimental | Drug: PitavastatinPitavastatin 2 mg or 4 mg once daily * The dosage is determined based on cholesterol levels and the physician's decision. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PitavastatinAlso: Livalo tabPitavastatin 2 mg or 4 mg once daily * The dosage is determined based on cholesterol levels and the physician's decision. | Drug | Pitavastatin |
Primary outcome
Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months
Time frame: 6 month
nmol BCE/L
7 secondary outcomes
Change in blood C-Telopeptide of Type I Collagen levels
Time frame: 6 and 12 months
Change in blood Osteocalcin levels
Time frame: 6 and 12 months
Change in urinary N-Telopeptide of Type I Collagen levels
Time frame: 6 and 12 months
Change in blood Procollagen Type 1 N-Terminal Propeptide levels
Time frame: 6 and 12 months
Change in blood LDL-cholesterol levels
Time frame: 6 and 12 months
Change in blood HbA1c levels
Time frame: 6 and 12 months
Changes in bone mineral density
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo Soo, M.D. Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitavastatin in people with Osteoporosis, Osteopenia and Hypercholesterolemia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.