A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture

Exclusion Criteria

• •2. Low BMD (BMD absolute value consistent with a T-score≤-2.5 and \>-4.0 at either the lumbar spine or total hip). The BMD equivalents by T-score thresholds for each DXA scanner manufacturer are provided below.
• •3. Have at least one of the following risk factors:
• •1. history of fragility fracture
• •2. parental history of hip fracture
• •3. low body weight (BMI≤19kg/m2)
• •4. elderly (age≥65y)
• •5. current smoker
• •4. Voluntarily signed written informed consent
• •1. Bone/metabolic disease:
• •1. Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,
• •2. Paget's disease
• •3. Cushing's disease
• •4. Hyperprolactinemia
• •5. Hypopituitarism
• •6. Acromegaly
• •7. Current hyperparathyroidism or hypoparathyroidism by medical record.
• •8. Current hyperthyroidism or hypothyroidism (allowed if having normal hormone level on thyroid hormone replacement therapy or 5.5μIU/mL\<thyroid-stimulating hormone (TSH) level≤10.0μIU/mL, but the serum thyroxine (T4) is within the normal range.
• •9. Malabsorption syndrome or any gastrointestinal disorders associated with malabsorption, for example 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 hydroxy vitamin D (25OHD) level \<20 ng/mL. (allowed 200,000 units of vitamin D2 injection (trade name: Futai®) once during the screening period, and re-test the 25OHD level once. Those with 25OHD level ≥20 ng/mL can be included
• •12. Others such as rheumatoid arthritis, gout, multiple myeloma and so on.
• •2. Subjects with a history of greater than 2 vertebral fractures.
• •3. Malignancy within the 5 years before enrollment (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ).
• •4. Severe renal disease, creatinine clearance \<30mL/min
• •5. Liver or biliary diseases:
• •1. Cirrhosis of the liver;
• •2. Biliary tract abnormalities (except asymptomatic gallstones);
• •3. Positive Hepatitis C virus (HCV) antibody;
• •4. Positive hepatitis B surface antigen (HBsAg) test with the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test ≥1×103 copies/mL (if positive HBsAg with the peripheral blood HBV DNA titer test \<1× 103 copies/mL, the subject is eligible for selection if the investigator believes that the subject is in a stable phase of chronic hepatitis B and will not increase the risk of the subject,;
• •5. Alkaline phosphatase \<lower limit of normal (LLN); alkaline phosphatase or total bilirubin ≥ 1.5 times the upper limit of normal (ULN); serum aspartate aminotransferase (AST) ≥ 2.0×ULN; serum alanine Acid aminotransferase (ALT) ≥2.0×ULN;
• •6. Oral/Dental Diseases
• •1. Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
• •2. Active dental or jaw condition which requires oral surgery.
• •3. Planned invasive dental procedure.
• •4. Non-healed dental or oral surgery.
• •7. DXA measurements:
• •1. Less than two lumbar vertebrae evaluable for DXA measurements.
• •2. Height, weight, or girth that could preclude accurate DXA measurements.
• •8. Administration of the following medications:
• •1. RANKL inhibitor, fluoride or strontium salt or intravenous bisphosphonate within the past 5 years;
• •2. Oral bisphosphonates, allowed if patients had the following conditions :
• •* Cumulative use\> 3 months but \<3 years: ≥ 6 months before the last medication was taken from the screening visit;
• •* Cumulative use ≤3 months;
• •3. parathyroid hormone (PTH) or parathyroid hormone analogs (PTHa) within 6 weeks before screening, such as teriparatide; anabolic hormones or testosterone; glucocorticoids (equivalent to\> 5 mg/day strength Pine\> 10 days); systemic hormone replacement therapy; selective estrogen receptor modulators (SERMs), such as raloxifene; tibolone; calcitonin; active vitamin D and its analogs; other bone active drugs including anticonvulsants (except benzodiazepines) and heparin; long-term systemic use of ketoconazole, androgens, corticotropin, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, Gonadotropin releasing hormone agonist;
• •9. Positive human immunodeficiency virus (HIV) antibody.
• •10. Self-reported alcohol or drug abuse \[defined as drinking an average of 14 units or more of alcoholic beverages per week in the 3 months before screening (1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine)\]
• •11. Known allergy to the treatment drugs used in the research protocol, including allergy to the test drugs
• •12. Have received any other experimental drug treatment or prior participation in another interventional clinical trial within 3 months before screening
• •13. Other severe acute or chronic diseases, psychiatric disorder or abnormal laboratory tests, etc., in the opinion of the investigator, not suitable for participating in this research.