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

NCT ID: NCT06154187

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2025-11-30

Brief Summary

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

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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test 1

PBK\_L2201

Group Type EXPERIMENTAL

PBK_L2201

Intervention Type DRUG

Abaloparatide-SC 80 μg was to be self-administered daily using a Pen Injector device.

placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo was formulated similar to abaloparatide-SC.

Interventions

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PBK_L2201

Abaloparatide-SC 80 μg was to be self-administered daily using a Pen Injector device.

Intervention Type DRUG

Placebo

Placebo was formulated similar to abaloparatide-SC.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pharmbio Korea Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Baek

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea Yeouido Saint Mary's Hospital

Locations

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The Catholic University of Korea Yeouido Saint Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Manager Clinical Trial team, Pharmbio Korea

Role: CONTACT

Phone: +82-2-587-2551

Email: [email protected]

Other Identifiers

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PBK_L2201_301

Identifier Type: -

Identifier Source: org_study_id