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

Phase 3

Not yet recruiting

• Conditions: Osteoporosis
• Interventions: Drug: PBK_L2201; Drug: Placebo

• Registration Number: NCT06154187
• Lead Sponsor: Pharmbio Korea Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-12-04
• Last Update Posted: 2023-12-04
• Study Start: 2024-02
• Primary Completion: 2025-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test 1	PBK_L2201	PBK_L2201
placebo	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The Catholic University of Korea Yeouido Saint Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of