Osteoporosis
Conditions
Brief summary
This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.
Interventions
DRUGPBK_L2201
Abaloparatide-SC 80 μg was to be self-administered daily using a Pen Injector device.
DRUGPlacebo
Placebo was formulated similar to abaloparatide-SC.
Sponsors
Pharmbio Korea Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density (BMD) change rate | 12 month | The % change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density (BMD) change | 12 month | The change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment. |
| Bone mineral density (BMD) % change | 6 and 18 month | The change & % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment. |
| % incidence of new non-vertebral fractures | 12 month | The % incidence of new non-vertebral fractures over 12 months of treatment |
Countries
South Korea
Contacts
Primary ContactManager Clinical Trial team, Pharmbio Korea
Outcome results
None listed