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

NCT06154187 | Unknown Phase 3

• 1 other identifier: PBK_L2201_301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Bone mineral density (BMD) change rate

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

  12 month

Secondary Outcomes (8)

• Bone mineral density (BMD) change

  12 month

• Bone mineral density (BMD) change

  6 and 18 month

• Bone mineral density (BMD) % change

  6 and 18 month

• Bone mineral density (BMD) change

  6, 12 and 18 month

• Bone mineral density (BMD) % change

  6, 12 and 18 month

Study Arms (2)

test 1

EXPERIMENTAL

PBK\_L2201

Drug: PBK_L2201

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

PBK_L2201 DRUG

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

test 1

Placebo DRUG

Placebo was formulated similar to abaloparatide-SC.

placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pharmbio Korea Co., Ltd.: lead

Study Sites (1)

The Catholic University of Korea Yeouido Saint Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Baek

  The Catholic University of Korea Yeouido Saint Mary's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manager Clinical Trial team, Pharmbio Korea

CONTACT

+82-2-587-2551; cr@pharmbio.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 4, 2023
• Study Start: February 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

KR (1)