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This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test 1 | Experimental | PBK_L2201 |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBK_L2201 | Drug | Abaloparatide-SC 80 μg was to be self-administered daily using a Pen Injector device. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manager Clinical Trial team, Pharmbio Korea | Contact | +82-2-587-2551 | cr@pharmbio.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Baek | The Catholic University of Korea Yeouido Saint Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea Yeouido Saint Mary's Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| Placebo | Drug | Placebo was formulated similar to abaloparatide-SC. |
|
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |