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The purpose of this study is to evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLG2128 | Experimental |
| |
| Teriparatide Injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLG2128 | Drug | Recommended dosage is 80 μg subcutaneously once daily,52week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week | Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week | Baseline to 52 Week |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week | Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week | Baseline to 26 Week |
| Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhenlin Zhang, Doctor | Contact | 13621673716 | zzl2002@medmail.com |
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| Teriparatide Injection |
| Drug |
Recommended dosage is 20μg subcutaneously once daily,52week |
|
Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week |
| Baseline to 26/52 Week |
| Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week | Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week | Baseline to 26/52 Week |
| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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