Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .

Korábbi kezelés

• Suffering from the following oral diseases:
  • Osteomyelitis or osteonecrosis of the jaw, previously or currently;
  • Actue dental or mandibular disease requiring stomatological surgery;
  • Planned invasive dental surgery during the trial period;
  • Dental or stomatological surgery have not healed;
• Received anti-osteoporosis drugs or those drugs may affect bone metabolism:
  • Use of injectable bisphosphonates, fluoride or strontium within 2 years before screening;
  • Use of oral bisphosphonates: more than 2 years, or more than 3 months but less than 2 years and discontinued from last dosage less than 1 year, simultaneously;
  • Usage of any drugs which may affect bone metabolism within 6 weeks before screening: parathyroid hormone or parathyroid hormone analogue(such as teriparatide); assimilative hormone or testosterone; glucocorticoid(equivalent to prednisone>5mg/day for more than 10 days); systemic hormone replacement therapy; selective estrogen receptor regulator(such as reloxifene); tibolone; calcitonin; active vitamin D and ite analogues, other bone active drugs include anticonvulsant drugs(except benzodiazepines) and he[arin; long-term systemic use of ketoconazole, androgen, adrenocorticotropic hormone, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonist;
  • Patients who have received RANKL inhibitors previously;
• Known alcoholism or drug abuse(during 12 months before screening), because alcohol or drug abuse may interfere with subject's understanding or finish of trial;
• Participate in interventionary clinical study(drug or device) within one month before screening;

Más betegség

• Medical history of two or more vertebrae fractures;
• Malignant tumor(excluding skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ or breast ductal carcinoma in situ) in recent 5 years;
• Suffering from the following liver or biliary diseases:
  • Liver cirrhosis;
  • Biliary abnormalities(except for Gilbert syndrome or asymptomatic gallstones);
  • Positive hepatitis C virus antibody(HCV-Ab) and the titer of HCV-RNA exceeded the upper limit of norma;
  • Positive hepatitis B suface antigen(HBsAg) and peripheral blood HBV-DNA titer ≥1000 capies[CPS]/mL or 200IU/mL;
  • Unstable liver disease: defined as liver ascites, hepatic encephalopathy, coagulopathy, hypoalbuminemia, varicosis in esophagus or stomach fundus or persistent hepatic jaundice;
• Conditions which can influence bone mineral density determination by dual energy X-ray absorptiometry:
  • Less than two lumbar vertebrae can be measured;
  • Height, weight or waistline may hinder accurate measurement;
  • Other conditions that may affect bone density testing
• Positive HIV antibody;
• Known allergy to test drug, reference drug or basic drug and its excipients;

Laborértékek

• Suffering from the following diseases known to affect calcium or bone metabolism:
  • Various metabolic bone diseases, such as osteogenesis imperfecta and osteomalacia;
  • Paget's osteopathy;
  • Cushing's syndrome;
  • Hyperprolactinemia;
  • Hypopituitarism;
  • Acromegaly;
  • History of hyperparathyroidism or hypoparathyroidism;
  • History of hyperthyroidism or hypothyroidism(hypothyroidism patients can be included: only receiving stable thyroid hormone replacement therapy, if the thyroid stimulating hormone(TSH) level is normal, or 5.5μIU/mL<TSH≤10.0μIU/mL, and free thyroxine(FT4) is in normal range can be included);
  • Malabsorption syndrome or various gastrointestinal diseases associated with malabsorption, such as Crohn's disease and chronic pancreatitis;
  • Abnormal level of blood calcium: the current diagnosis of hypocalcemia or hypercalcemia or albumin corrected serum calcium levels are not within the laboratory normal range(calcium supplements should not be used for at least 8 hours prior to serum calcium testing);
  • Vitamin D deficiency: 25 hydroxyvitamin D concentration<20ng/mL. Allowed to retest after oral vitamin D2 soft capsules in the screening period. If the concentration of 25 hydroxyvitamin D is more than or equal to 20ng/mL， it can be selected;
  • Other diseases such as rheumatoid arthritis, gout, multiple myeloma, etc;
• Severe renal function damage(creatinine clearance rate<30mL/min), or dialysis, urinary calculi or chronic cystitis;
• Liver transaminase: aspartate aminotransferase≥2.0×upper limit of norma value(ULN), alanine aminotransferase≥2.0ULN, alkaline phosphatase≥1.5ULN or total bilirubin≥1.5ULN;
• Other serious, acute or chronic diseases, mental disorders or laboratory abnormalities, which are judged by investigator to be unsuitable to participate this study.

• Fully informed, understood, voluntary participate, and the patient himself or guardian agree to sign the written informed consent and patient be able to comply with the protocol;
• Aged from 50 years to 85 years, inclusive;
• Spontaneous amenorrhea time ≥ 2 years, or bilateral oophorectomy≥ 2 years. If the status of bilateral ovariectomies is unknown, the menopause status should be confirmed by follicle stimulating hormone(FSH) level≥ 40IU/L;
• Based on the results of dual energy X-ray absorptiometry, BMD of lumbar spine(L1~L4), femoral neck or total hip: -4.0<T-Score≤-2.5；
• There must be at least one of the following risk factors:
  • History of osteoporotic fracture;
  • Father's and mother's hip fracture history, or both parents';
  • Low body mass index(≤19kg/m\^2);
  • Patient's age was equal or greater than 70 years old;
  • Current smoker;
  • CTX1 was one standard deviation higher than that of healthy premenopausal women within screening period(ie, CTX1>0.43ng/mL);
• Ability to act independently.