Treatment of postmenopausal women with osteoporosis at high risk for fracture
Conditions
Interventions
Full human recombinant monoclonal antibody against RANKL for injection:A single dose of 60 mg will be administered subcutaneously.
Prolia :A single dose of 60 mg will be administered subcutaneously.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Sign informed consent before study, and fully understand the content, process and possible side effects; 2) Comply with the requirements of the study protocol; 3) Male and female subjects aged 18~65 years (including 18 and 65 years); 4) Male subjects weight =55 kg, and female subjects weight=45 kg. Body mass index (BMI) = body weight (kg) / height 2 (M2), BMI=18 and =28 kg/m2; 5) Physical examination and vital signs are normal or abnormal clinically irrelevant.
Exclusion criteria
Exclusion criteria: 1) Smoke =5 cigarettes or the equivalent per day within 3 months prior to the study; 2) History of sensitivity to the study medications, sensitivity to multiple drugs and food, or sensitivity to calcium and/or vitamin D; 3) Those who have a history of alcohol abuse or who have had a history of drug abuse or drug use in the past five years (14 units of alcohol per week: 1 unit = beer 285mL, or spirits 25mL, or wine 100mL); 4) Blood donation or massive blood losing (>450mL) within 3 months prior to the screening; 5) Take any liver enzyme activity relative drug within 28 days prior to the screening; 6) Use any prescription, over-the-counter, any vitamin product or herbal medicine within 14 days of screening; 7) There have been major changes in diet or exercise habits recently; 8) The research drug was used within the first three months of the study, or participated in the drug clinical trial; 9) Abnormal electrocardiogram [ECG] findings with clinically relevance; 10) Abnormal laboratory tests with clinically relevance, or other clinical findings with clinical relevance (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardio-cerebrovascular disease); 11) Viral hepatitis (including hepatitis B and hepatitis C), HIV, and Treponema pallidum positive; 12) Acute disease or combination therapy from the screening to the beginning time of the study; 13) Take chocolate, any caffeine-containing or xanthine-rich food or drinks within 48 hours prior to using the drug; 14) Those who have taken any alcoholic products or alcohol breath test positive within 24 hours before the study; 15) Urine drug screening positive; 16) A prior history or current evidence of osteomyelitis or ONJ ,an active dental or jaw condition that requires oral surgery , a non-healed dental or oral surgery and a planned invasive dental procedure during the course of the study; 17) Liver disease or a history of chronic liver disease, or known hepatobiliary abnormalities (except Gilbert syndrome and asymptomatic biliary calculi), abnormalities clinical significantly judged by researchers of the study; 18) Bone-related surgery performed within 1 month before enrollment; 19) A history of lumbar disc herniation; 20) Abnormal serum calcium: those who are prone to hypocalcemia (hypoparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndrome, and history of small bowel resection) or have a history of hypocalcemia; current hypocalcemia or hypercalcemia clinically significant; 21) Prior use of medications within one month or 5 half-lives (whichever period is greater) before and during the study. This includes medications such as, but not limited to: Estrogen-containing contraceptives Bisphosphonates Fluoride Hormone replacement therapy (i.e., tibolone, estrogen, estrogen-like compounds such as raloxifene) Calcitonin Strontium Parathyroid hormone or derivatives Supplemental vitamin D (>1000 IU/day) Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) Anabolic steroids Calcitriol Diuretics; 22) Unwilling or unable to follow the procedures described in this research protocol; 23) Pregnant females as determined by positive serum human chorionic gonadotropin (hCG) test at screening or urine hCG test prior to dosing (day -1); men and women unwilling to take adequate contraceptive measures within 9 months after screening and u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC 0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;AUC 0- 8;T max;CL;? z;t 1/2;Vd; | — |
Countries
China
Contacts
Public ContactDing Yanhua
The First Hospital of Jilin University
Outcome results
None listed