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This study is a multicenter, randomized, double-blind comparative study to valuating the efficacy and safety of QL1206 and Prolia® in postmenopausal women with osteoporosis at high risk of fracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1206 | Experimental | QL1206 Denosumab injection(60 mg) |
|
| Prolia® | Active Comparator | Prolia® Denosumab injection(60 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1206 | Drug | QL1206 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in lumbar spine(LS)-BMD at Month 12 | Percent Change From Baseline in lumbar spine(LS)-BMD at Month 12 | Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youjia Xu | Contact | +86-0512-67783682 | sdfeyec@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital Bijie Hospital | Recruiting | Guizhou | China |
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| ID | Term |
|---|---|
| C000729682 | QL1206 |
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Prolia® | Drug | Prolia® Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial. |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |