Osteoporosis
Conditions
Interventions
Experimental group:LY06006 injection 60mg, the control group was given a placebo, both were 1mL, subcutaneously injected, administered every 6 months until the 12th month, a total of 2 times
Control group:Placebo
1mL, subcutaneous injection, administered every 6 months, up to 12 months, a total of 2 doses
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
Female
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women aged 50 to 85 years who have the ability of independent activity. Postmenopause is defined as menopause time >=3 years, i.e. spontaneous amenorrhea >=3 years or bilateral oophorectomy >=3 years. For the patients with hysterectomy but ovarian preservation, the menopause should be confirmed by FSH level >=40 U/L; 2. Based on the measurement results of bone mineral density (BMD) by dual energy X-ray absorptiometry (DXA), the BMD t-value of lumbar spine (L1-L4) or total hip is less than - 2.5, and the BMD t-value of any part should be more than - 4.0/l; 3. Patients with at least one of the following risk factors: (1) Previous history of brittle fracture, such as hip, distal radius or vertebral fracture; (2) Father or mother hip fracture history; (3) Low body mass index (BMI =65 years old); (5) Smoking at present; 4. Patients who voluntarily participated in the trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with the following known disorders affecting calcium or bone metabolism: (1) Various metabolic osteopathy, such as osteogenesis imperfectness and osteomalacia; (2) Paget's disease; (3) Cushing's syndrome; (4) Hyperprolactinemia; (5) Hypophysis; (6) Acromegaly; (7) Parathyroid diseases: history of hyperparathyroidism or hypoparathyroidism; (8) Thyroid disease: Patients with history of hyperthyroidism or hypothyroidism, but with stable thyroid hormone replacement therapy, if the hormone level is normal or TSH level 5.5 to 10.0 uIU/ml, but the serum thyroxine (T4) in the normal range can be selected; (9) Malabsorption syndrome or various gastrointestinal diseases related to malabsorption, such as Crohn's disease and chronic pancreatitis; (10) Hypocalcemia or hypercalcemia, or serum albumin corrected blood calcium level is not within the normal range of the laboratory; (11) Vitamin D deficiency: 25 hydroxyvitamin D (25OHD) concentration =20 ng / ml can be included in the group; 2. Patients with other diseases such as rheumatoid arthritis, gout, multiple myeloma, etc. 3. Patients with 2 or more lumbar fractures; 4. Patients with malignant tumors: malignant tumors in recent 5 years (except for completely excised in situ skin basal cell or squamous cell carcinoma, cervical cancer or breast duct cancer); 5. In patients with severe kidney disease, the clearance rate of creatinine (CR) was less than 30 ml/min; 6. Patients with the following liver or biliary diseases: (1) Cirrhosis; (2) Abnormal bile duct (except for asymptomatic gallstones); (3) Hepatitis C virus (HCV) antibody was positive; (4) If HBsAg is positive and the titer of HBV DNA in the peripheral blood >=1x10^3 copies/ml, and the titer of HBV DNA in the peripheral blood is =1.5 ULN; aspartate transaminase (AST) >=2.0 ULN; alanine transaminase (ALT) >=2.0 ULN; 7. Patients with the following oral and dental diseases: (1) Previous or current cases of osteomyelitis or osteonecrosis of the mandible; (2) Acute dental or mandibular disease requiring oral surgery; (3) During the trial, invasive dentistry was planned; (4) Dental or oral surgery is not cured; 8. Influence of DXA bone mineral density measurement: (1) There are less than two lumbar vertebrae that can be measured by DXA; (2) Height, weight or waistline may hinder the accurate measurement of DXA; 9. Those who have received anti osteoporosis treatment or drugs affecting bone metabolism: (1) In the past 5 years, they received RANKL inhibitor, fluoride or strontium salt treatment or intravenous bisphosphonate; (2) Patients taking bisphosphonates orally, but with the following conditions, can be included in the group: Cumulative use > 3 months but =6 months; Cumulative use 5 Mg/day prednisone > 10 days); syst
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change rate of lumbar BMD from baseline at 6 months of treatment;Change rate of total hip, femoral neck and trochanteric BMD from baseline at 6 and 12 months of treatment;Rates of change in serum type-I collagen C-terminal peptide cross-linking (S-CTX) and serum type-I procollagen N-terminal propeptide (P1NP) from baseline at 1, 6, 12 months; | — |
Primary
| Measure | Time frame |
|---|---|
| Change rate of lumbar BMD from baseline at 12 months of treatment; | — |
Countries
China
Contacts
Public ContactZhenlin Zhang
Shanghai Sixth People's Hospital
Outcome results
None listed