Status unknownNCT06154187Updated Dec 4, 2023

Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis

A Phase 3 interventional study of PBK_L2201 and Placebo in Osteoporosis, sponsored by Pharmbio Korea Co., Ltd.. Status unknown at 1 site in South Korea. Open to female participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-12-04.

Sponsored by Pharmbio Korea Co., Ltd. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 50 Years to 85 Years
Sex: Female

Study summary

This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.

Conditions studied

Osteoporosis

Browse trials for

Osteoporosis 1,675

In context

Osteoporosis

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

This study's planned enrollment of 60 is below the median of 95 across 1,152 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Pharmbio Korea Co., Ltd. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

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

Who can participate

Ages eligible: 50 Years to 85 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

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

Exclusion criteria

Exclusion Criteria:

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).

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 60 participants (estimated)

Study arms

Experimental
test 1
PBK\_L2201
Drug: PBK_L2201
Placebo comparator
placebo
placebo
Drug: Placebo

Interventions

DrugPBK_L2201
Abaloparatide-SC 80 μg was to be self-administered daily using a Pen Injector device.
DrugPlacebo
Placebo was formulated similar to abaloparatide-SC.

What researchers measure

Primary outcomes

Bone mineral density (BMD) change rate
The % change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.
Time frame: 12 month

Secondary outcomes

Bone mineral density (BMD) change
The change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6, 12 and 18 month
% incidence of new non-vertebral fractures
The % incidence of new non-vertebral fractures over 12 months of treatment
Time frame: 12 month

Study locations

1 site

The Catholic University of Korea Yeouido Saint Mary's Hospital
Seoul, South Korea
- Baek · Principal investigator

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

Start is estimated for Feb 2024; primary completion for May 2025, 15 months later.

Of 49 industry-sponsored phase 3 interventional studies under Osteoporosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 43. This study's planned 15 months is below that.

Counting every sponsor, half of 58 studies reached it within 26 months; a quarter within 19 and three quarters within 44.

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

Registered: Nov 20, 2023
First posted: Dec 4, 2023
StartEst.: Feb 2024
Primary completionEst.: May 2025
CompletionEst.: Nov 2025
Last update: Dec 4, 2023

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 Dec 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06154187
Lead sponsor: Pharmbio Korea Co., Ltd.
Responsible party: Sponsor
First posted: Dec 4, 2023
Start date: Feb 2024 (estimated)
Primary completion: May 2025 (estimated)
Completion: Nov 2025 (estimated)
Last update: Dec 4, 2023

Study contacts

Manager Clinical Trial team, Pharmbio Korea

Contact

cr@pharmbio.co.kr

+82-2-587-2551

Baek

principal investigator · The Catholic University of Korea Yeouido Saint Mary's Hospital

Oversight

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

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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