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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06154187
• Other study ID #: PBK_L2201_301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 2024
• Est. completion date: November 2025

Study information

• Verified date: November 2023
• Source: Pharmbio Korea Co., Ltd.
• Contact: Manager Clinical Trial team, Pharmbio Korea
• Phone: +82-2-587-2551
• Email: cr[@]pharmbio.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• PBK_L2201
Abaloparatide-SC 80 µg was to be self-administered daily using a Pen Injector device.
• Placebo
Placebo was formulated similar to abaloparatide-SC.

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Yeouido Saint Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pharmbio Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bone mineral density (BMD) change	The change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.	12 month
Secondary	Bone mineral density (BMD) change	The change & % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment.	6 and 18 month
Secondary	Bone mineral density (BMD) % change	The change & % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment.	6 and 18 month
Secondary	Bone mineral density (BMD) change	The change & % change from baseline in total hip Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.	6, 12 and 18 month
Secondary	Bone mineral density (BMD) % change	The change & % change from baseline in total hip Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.	6, 12 and 18 month
Secondary	Bone mineral density (BMD) change	The change & % change from baseline in femoral neck Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.	6, 12 and 18 month
Secondary	Bone mineral density (BMD) % change	The change & % change from baseline in femoral neck Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.	6, 12 and 18 month
Secondary	% incidence of new non-vertebral fractures	The % incidence of new non-vertebral fractures over 12 months of treatment	12 month