Clinical trial NCT06154187: Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Pharmbio Korea Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Bone mineral density (BMD) change rate
timeFrame: 12 month
Secondary outcomes:
measure: Bone mineral density (BMD) change
timeFrame: 12 month
measure: Bone mineral density (BMD) change
timeFrame: 6 and 18 month
measure: Bone mineral density (BMD) % change
timeFrame: 6 and 18 month
measure: Bone mineral density (BMD) change
timeFrame: 6, 12 and 18 month
measure: Bone mineral density (BMD) % change
timeFrame: 6, 12 and 18 month
measure: Bone mineral density (BMD) change
timeFrame: 6, 12 and 18 month
measure: Bone mineral density (BMD) % change
timeFrame: 6, 12 and 18 month
measure: % incidence of new non-vertebral fractures
timeFrame: 12 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Yeouido Saint Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea Yeouido Saint Mary's Hospital
name: Baek
role: PRINCIPAL_INVESTIGATOR
References: