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| Name | Class |
|---|---|
| Salubris (Suzhou) Pharmaceutical Co., Ltd. | UNKNOWN |
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This is a multicenter, randomized, open-label, parallel-controlled Phase II study designed to evaluate the differences in safety among four different dosing regimens of SAL056.
This study will randomly assign 200 eligible trial participants to either the intervention group or the control group, with each treatment group receiving an 8-week course of the investigational drug. By comparing the incidence of safety events between the groups at the end of the treatment period, the safety differences among the four different medication regimens will be evaluated.
The study is primarily divided into a screening period (up to 4 weeks before administration), a treatment period (8 weeks), and a safety follow-up period of 1 week, requiring a total of 7 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Experimental | SAL056 56.5μg administered once weekly for 8 weeks |
|
| Intervention Group 1 | Other | Teriparatide Injection daily formulation administered for 2 weeks, followed by SAL056 for 6 weeks; |
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| Intervention Group 2 | Other | Teriparatide Injection daily formulation administered for 4 weeks, followed by SAL056 for 4 weeks; |
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| Intervention Group 3 | Other | SAL056 28.2μg administered twice weekly for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAL056 56.5μg | Drug | SAL056 56.5μg administered once weekly for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) between each intervention group and the control group during the treatment period,about 10weeks | during the treatment period,about 10 weeks |
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Inclusion Criteria:
1.Female, with independent mobility, 45 years ≤ age ≤ 80 years; 2.Natural menopause for ≥3 years, or surgical menopause for ≥3 years (surgery must be performed after age 40); for women with surgical menopause, follicle-stimulating hormone >40 mIU/mL is required; 3.18 ≤ body mass index ≤ 30 kg/m²; 4.Previous definitive diagnosis of osteoporosis; 5.Patients who are able to independently go to the hospital to receive injections of the investigational drug; 6. Voluntarily participate in this trial and sign the informed consent form.
Exclusion Criteria:
1) Alkaline phosphatase >1.3 times the upper limit of normal; 2) Alanine aminotransferase or aspartate aminotransferase >3.0 times the upper limit of normal; 3)Total bilirubin >1.5 times the upper limit of normal; 4) Glycated hemoglobin ≥8.5%; 5)White blood cell count <3.0×10⁹/L, or hemoglobin <100g/L, or platelet count <90×10⁹/L; 6)Parathyroid hormone >1.5 times the upper limit of normal; 8. Positive for hepatitis C virus antibody, or Treponema pallidum antibody, or human immunodeficiency virus antibody; or positive for hepatitis B surface antigen (HBsAg) with peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer ≥1×103 copies/mL (if HBsAg is positive and peripheral blood HBV DNA titer <1×103 copies/mL, the trial participant is eligible if the investigator considers the participant's chronic hepatitis B to be in a stable phase and will not increase the risk to the trial participant); 9. History of major surgery (excluding fracture surgery) within 6 months prior to signing the informed consent form, or planned major surgery during the study period; 10. Known history of organ transplantation; 11. History of drug abuse within 6 months prior to informed consent; 12. Individuals with known allergy to the investigational drug; 13. Patients who have previously received radiation therapy to the skeletal system; 14. Individuals with mental illness or cognitive impairment due to any cause; 15. Patients deemed unsuitable to participate in this study by researchers based on risk-benefit considerations.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weishi Li, Professor | Contact | 13501358705 | weishi_li@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 230088 | China |
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| Intervention Group 1 |
| Drug |
Teriparatide Injection daily formulation administered for 2 weeks, followed by SAL056 for 6 weeks. |
|
| Intervention Group 2 | Drug | Teriparatide Injection daily formulation administered for 4 weeks, followed by SAL056 for 4 weeks. |
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| Intervention Group 3 | Drug | SAL056 28.2μg administered twice weekly for 8 weeks. |
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