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

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

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: PBK_L2201
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test 1<br>PBK_L2201 | Drug: PBK_L2201<br>* Abaloparatide-SC 80 μg was to be self-administered daily using a Pen Injector device.<br>|
| Placebo Comparator: placebo<br>placebo | Drug: Placebo<br>* Placebo was formulated similar to abaloparatide-SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density (BMD) change | The change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment. | 12 month | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| % incidence of new non-vertebral fractures | The % incidence of new non-vertebral fractures over 12 months of treatment | 12 month |