Status:
UNKNOWN
Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis
Lead Sponsor:
Pharmbio Korea Co., Ltd.
Conditions:
Osteoporosis
Eligibility:
FEMALE
50-85 years
Phase:
PHASE3
Brief Summary
This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06154187
Start Date
February 1 2024
End Date
November 1 2025
Last Update
December 4 2023
Active Locations (1)
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1
The Catholic University of Korea Yeouido Saint Mary's Hospital
Seoul, South Korea