OsteoporosisPhase 3NCT06154187
Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis
A Phase 3 study testing PBK_L2201 in people with Osteoporosis, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.
Trial summary
This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- PBK_L2201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2024to Nov 2025
- Phase
- Phase 3
- 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 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a healthy ambulatory postmenopausal woman from 50 to 85 years of age (inclusive) with osteoporosis.
- Be postmenopausal for at least 5 years. Postmenopausal status was established by a history of amenorrhea for at least 5 years and by an elevated serum follicle-stimulating hormone (FSH) value of ≥30 IU/L.
- Be to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low-trauma femoral, radius, humerus, sacral, pelvic, or ankle fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and > -5.0
Who cannot join
- History of more than 4 spine fractures, mild or moderate, or any severe fractures.
- Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least 2 radiologically evaluable vertebrae within L1-L4.
- Unevaluable hip Bone mineral density (BMD) or patients who had undergone bilateral hip replacement (unilateral hip replacement was acceptable).
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Yeouido Saint Mary's Hospital
Seoul
Baek
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis
This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.
- Conditions
- Osteoporosis
- Being tested
- PBK_L2201, Placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBK_L2201Drug
Abaloparatide-SC 80 μg was to be self-administered daily using a Pen Injector device.
PlaceboDrug
Placebo was formulated similar to abaloparatide-SC.
| Study group | Role | What they receive |
|---|---|---|
| test 1 | Experimental | PBK_L2201 Receives: Drug: PBK_L2201 |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density (BMD) change rate
The % change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.
Measured: 12 month
Secondary outcomes (8)
Bone mineral density (BMD) change
The change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.
Measured: 12 month
Bone mineral density (BMD) change
The change \& % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment.
Measured: 6 and 18 month
Bone mineral density (BMD) % change
The change \& % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment.
Measured: 6 and 18 month
Bone mineral density (BMD) change
The change \& % change from baseline in total hip Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Measured: 6, 12 and 18 month
Bone mineral density (BMD) % change
The change \& % change from baseline in total hip Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Measured: 6, 12 and 18 month
Bone mineral density (BMD) change
The change \& % change from baseline in femoral neck Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Measured: 6, 12 and 18 month
Bone mineral density (BMD) % change
The change \& % change from baseline in femoral neck Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Measured: 6, 12 and 18 month
% incidence of new non-vertebral fractures
The % incidence of new non-vertebral fractures over 12 months of treatment
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study startFeb 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmbio Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baek, Principal investigator, The Catholic University of Korea Yeouido Saint Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154187
- Sponsor's protocol ID
- PBK_L2201_301
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT06154187
- Acronym / sponsor ID
- PBK_L2201_301
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pharmbio Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 4 Dec 2023 (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 was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test 1 | Experimental | Drug: PBK_L2201PBK_L2201 |
| placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be a healthy ambulatory postmenopausal woman from 50 to 85 years of age (inclusive) with osteoporosis.
- Be postmenopausal for at least 5 years. Postmenopausal status was established by a history of amenorrhea for at least 5 years and by an elevated serum follicle-stimulating hormone (FSH) value of ≥30 IU/L.
- Be to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low-trauma femoral, radius, humerus, sacral, pelvic, or ankle fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and > -5.0
Key exclusion criteria (3 listed)
- History of more than 4 spine fractures, mild or moderate, or any severe fractures.
- Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least 2 radiologically evaluable vertebrae within L1-L4.
- Unevaluable hip Bone mineral density (BMD) or patients who had undergone bilateral hip replacement (unilateral hip replacement was acceptable).
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 |
|---|---|---|
| PBK_L2201Abaloparatide-SC 80 μg was to be self-administered daily using a Pen Injector device. | Drug | test 1 |
| PlaceboPlacebo was formulated similar to abaloparatide-SC. | Drug | placebo |
Primary outcome
Bone mineral density (BMD) change rate
Time frame: 12 month
The % change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.
8 secondary outcomes
Bone mineral density (BMD) change
Time frame: 12 month
Bone mineral density (BMD) change
Time frame: 6 and 18 month
Bone mineral density (BMD) % change
Time frame: 6 and 18 month
Bone mineral density (BMD) change
Time frame: 6, 12 and 18 month
Bone mineral density (BMD) % change
Time frame: 6, 12 and 18 month
Bone mineral density (BMD) change
Time frame: 6, 12 and 18 month
Bone mineral density (BMD) % change
Time frame: 6, 12 and 18 month
% incidence of new non-vertebral fractures
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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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.
Baek principal investigator
The Catholic University of Korea Yeouido Saint Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PBK_L2201 in people with Osteoporosis, run by Pharmbio Korea Co., Ltd. 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manager Clinical Trial team, Pharmbio Korea (+82-2-587-2551, cr@pharmbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (BMD) change rate (time frame: 12 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 4 Dec 2023.