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

Sponsor

Pharmbio Korea Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06154187

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: PBK_L2201 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2024

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: test 1 PBK_L2201	Drug: PBK_L2201 Abaloparatide-SC 80 μg was to be self-administered daily using a Pen Injector device.
Placebo Comparator: placebo placebo	Drug: Placebo Placebo was formulated similar to abaloparatide-SC.

Arm

Intervention/Treatment

Experimental: test 1

PBK_L2201

Drug: PBK_L2201

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

Placebo Comparator: placebo

placebo

Drug: Placebo

Placebo was formulated similar to abaloparatide-SC.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Bone mineral density (BMD) change [12 month]
The change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.
Bone mineral density (BMD) change [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 [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 [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 [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 [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 [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 [12 month]
The % incidence of new non-vertebral fractures over 12 months of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Catholic University of Korea Yeouido Saint Mary's Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Pharmbio Korea Co., Ltd.

Investigators

Principal Investigator: Baek, The Catholic University of Korea Yeouido Saint Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pharmbio Korea Co., Ltd.

ClinicalTrials.gov Identifier:

NCT06154187

Other Study ID Numbers:

PBK_L2201_301

First Posted:

Dec 4, 2023

Last Update Posted:

Dec 4, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoporosis

Study Results

No Results Posted as of Dec 4, 2023