Osteoporosis in postmenopausal women
Conditions
Interventions
Experimental group: SAL056 group:SAL056: One (56.5µg) was dissolved in 1mL water for injection, and injected subcutaneously, once a week, into the thigh or abdominal wall. D calcium chewable tablets (
Control group: alendronate sodium group:Alendronate sodium (fosamax) : fasting oral, 1 tablet, once a week
How to take the medicine: take it with a cup of water (about 250mL) after morning, fast within 30 minutes and keep standing or sitting up straight
D calcium chewable tablets (Diqiao) : oral, chewed and swallowed, 2 tablets&
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
Female
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria All subjects in this study can meet the following criteria: 1) Female, with independent activity ability, 45 years old = age = 80 years old; 2) Natural menopause for 3 years or more, or surgical menopause for 3 years or more (surgery should be performed after the age of 40); For surgically menopausal women, follicle stimulating hormone > 40m IU / ml is required; 3) 18 = body mass index = 30 kg / m2; 4) Meet one of the following diagnostic criteria of osteoporosis, and there are at least two continuous vertebral bodies in L1 ~ L4. The bone mineral density can be measured by DXA method: a) Brittle fracture of hip or vertebral body, and the measured t-value of bone mineral density is less than - 1.0; b) The bone mineral density t-value of axial bone (lumbar spine, femoral neck or total hip) measured by DXA is = - 2.5; c) BMD measurement was consistent with low bone mass (- 2.5 < t-value < - 1.0) and complicated with brittle fractures of proximal humerus, pelvis or distal forearm; 5) Voluntarily participate in the experiment and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with secondary osteoporosis, such as Cushing's syndrome, hyperprolactinemia, malabsorption syndrome or various gastrointestinal diseases associated with malabsorption (such as Crohn's disease, chronic pancreatitis, etc.), rheumatoid arthritis, gout, multiple myeloma, etc.; 2. Patients with other diseases affecting calcium or bone metabolism, including hyperparathyroidism or hypothyroidism, hyperthyroidism or hypothyroidism (hyperthyroidism or hypothyroidism with stable treatment and normal hormone levels may be included; Or 5.5 mIU/L =6 months before signing the informed consent, or patients who have received treatment with parathyroid hormone and its analogues within 3 months before signing the informed consent; (2) Patients who had received continuous oral bisphosphonate treatment for >=3 years before signing the informed consent; Or 3 months =3 years before signing the informed consent, or receiving treatment with bisphosphonate injection once or more within 2 years before signing the informed consent; (4) Patients who received RANKL inhibitor treatment 6 months before signing the informed consent; (5) Patients receiving androgen, estrogen and selective estrogen receptor modulator continuously for more than 4 weeks within 2 months before signing the informed consent; (6) Patients who received active vitamin D and its analogities (alfacalcitol, calcitriol) within 2 weeks before signing the informed consent; 4. Patients who received drugs that affect bone metabolism, such as heparin, warfarin, thiazolidinediones, SGLT-2 inhibitors, systemic (oral, intramuscular, intravenous) glucocorticoids, anticonvulsants (excluding benzodiazepines) within 3 months before signing the informed consent; 5. Patients requiring long-term or continuous use of digoxin and other digitalis during the trial; 6. Severe kidney disease (serum creatinine > 1.2 times the upper limit of normal), uncontrolled hypertension [systolic blood pressure >=150mmHg and/or diastolic blood pressure >=100mmHg], serious heart disease (such as myocardial infarction, unstable angina, heart failure with NYHA grade III-IV, severe arrhythmia, etc.), cerebral infarction (except lacunar cerebral infarction) ) or arteriosclerosis obliterans, malignant neoplasms, and other serious underlying diseases; 7. Patients with esophageal abnormalities (such as reflux esophagitis, esophageal stenosis or delayed inability) or dysphagia resulting in delayed emptying of the esophagus; 8. Laboratory examination during the screening period found abnormal indicators, including any of the following indicators: (1) Alkaline phosphatase > 1.2 times the upper limit of normal value; (2) Alanine aminotransferase, or aspartate aminotransf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in lumbar bone mineral density (L1 to L4) from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change rate of total hip bone density from baseline;Lumbar spine (L1 ~ L4) change rate of bone mineral density from baseline;S-CTX and PINP Rate of change from baseline; | — |
Countries
China
Contacts
Public ContactHui Lin
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Outcome results
None listed