DRUG
PBK_L2201
Abaloparatide-SC 80 μg was to be self-administered daily using a Pen Injector device.
Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis
Status
Unknown
Phase
Phase 3
Enrollment
60
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.
Interventions
Treatment arms and agents.
DRUG
Placebo
Placebo was formulated similar to abaloparatide-SC.
Timeline
From registration to results.
First posted
Dec 4, 2023
Study start
Feb 2024
Primary completion
May 2025
Study completion
Nov 2025
Results posted
Not reported
Registry updated
Dec 4, 2023
Outcomes
What the study measures.
Primary outcomes
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.
Secondary outcomes
Bone mineral density (BMD) change
Time frame · 12 month
The change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.
Bone mineral density (BMD) change
Time frame · 6 and 18 month
The change \& % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment.
Bone mineral density (BMD) % change
Time frame · 6 and 18 month
The change \& % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment.
Bone mineral density (BMD) change
Time frame · 6, 12 and 18 month
The change \& % change from baseline in total hip Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Bone mineral density (BMD) % change
Time frame · 6, 12 and 18 month
The change \& % change from baseline in total hip Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Bone mineral density (BMD) change
Time frame · 6, 12 and 18 month
The change \& % change from baseline in femoral neck Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Bone mineral density (BMD) % change
Time frame · 6, 12 and 18 month
The change \& % change from baseline in femoral neck Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
% incidence of new non-vertebral fractures
Time frame · 12 month
The % incidence of new non-vertebral fractures over 12 months of treatment
Eligibility
Who can take part.
- Minimum age
- 50 Years
- Maximum age
- 85 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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: * 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 locations
1 registered sites.
South Korea. Showing up to 24 locations stored in the fast local snapshot.
The Catholic University of Korea Yeouido Saint Mary's Hospital
Seoul, South Korea
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Abaloparatide.
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