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

Pharmbio Korea

Status and phase: Not yet enrolling; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Placebo; Drug: PBK_L2201

Study type: Interventional

Funder types: Industry

Identifiers

NCT06154187

PBK_L2201_301

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 50 to 85 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

test 1

Experimental group

Description:

PBK_L2201

Treatment:

Drug: PBK_L2201

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo