Osteoporosis
Conditions
Interventions
Control group:SAL056 56.5µg administered once weekly for 8 weeks
Intervention Group 1:Teriparatide daily formulation administered for 2 weeks, followed sequentially by SAL056 administration for 6 weeks
Intervention Group 2:Teriparatide daily formulation administered for 4 weeks, followed sequentially by SAL056 administration for 4 weeks
Intervention Group 3:SAL056 28.2µg administered twice weekly for 8 weeks.
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Female
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Female, with independent mobility, 45 years =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/m^2; 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
Exclusion criteria: 1. Received teriparatide treatment within 1 month prior to screening; 2. Patients with secondary osteoporosis, such as Cushing's syndrome, hyperprolactinemia, malabsorption syndrome or various gastrointestinal diseases related to malabsorption (such as Crohn's disease, chronic pancreatitis, etc.), rheumatoid arthritis, gout, multiple myeloma, etc.; 3. Patients with other diseases affecting calcium or bone metabolism, including hyperparathyroidism or hypoparathyroidism, hyperthyroidism or hypothyroidism (patients with hyperthyroidism or hypothyroidism receiving stable treatment with normal hormone levels are eligible; or patients with hypothyroidism where 5.5 mIU/L 1.5 times the upper limit of normal), uncontrolled hypertension [systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg], severe heart disease (such as myocardial infarction, unstable angina pectoris, heart failure with NYHA functional class III-IV, severe arrhythmias, etc.), cerebral infarction (excluding lacunar cerebral infarction) or occlusive arteriosclerosis, malignant tumors, and those with other serious underlying diseases; 6. Patients with esophageal abnormalities that cause delayed esophageal emptying (such as reflux esophagitis, esophageal stricture or achalasia) or those with difficulty swallowing; 7. Abnormal laboratory findings detected during the screening period, including any of the following abnormal indicators: 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 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 >=1×10^3 copies/mL (if HBsAg is positive and peripheral blood HBV DNA titer <1×10^3 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of treatment-emergent adverse events (TEAE) between each intervention group and the control group during the treatment period;;The incidence of treatment-related adverse events (TRAE) between each intervention group and the control group during the treatment period;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the safety characteristics among four different medication regimens;;Assessment of changes in bone turnover markers from baseline after treatment; | — |
Countries
China
Contacts
Public ContactWeishi Li
Peking University Third Hospital
Outcome results
None listed