Osteoporosis in menopause women
Conditions
Interventions
A1:25µg
A2:50µg
A3:75µg
A4:100µg
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must meet all the following criteria to be selected: 1) Chinese healthy volunteers aged 18-45 years old, with the same age difference of 10 years old, and half and half of men and women; 2) male weight more than 50kg, the female weight is greater than or equal to 45kg; BMI (BMI= (kg) according to the weight / height 2 (M2) calculation) between 19-26 kg/m2 (including boundary value); 3) the subjects understood and accepted the process and restriction of this study, volunteered to participate in this clinical study and signed a written informed consent.
Exclusion criteria
Exclusion criteria: The subjects who conform to one or more of the following criteria will be excluded: 1) the history of diseases, such as heart, liver, lung, kidney, digestive tract, endocrinology, metabolism and blood system, was determined by the researchers; 2) the history of parathyroid disease; 3) physical examination, laboratory examination, electrocardiogram (ECG), chest radiograph, abdominal B ultrasound and vital signs examination suggested that the subjects were clinically abnormal. 4) serum total calcium, research center of the upper limit of normal or had hypercalcaemia and calcium regulation disorders lead to hypercalcemia; 5) the patients with high serum uric acid (female serum uric acid > 360 mol/L, male serum uric acid > 420 mol/L); 6) in the first 3 months, urolithiasis or B-mode ultrasonography in patients with urinary calculi were selected. 7) for the first time test before administration of drugs within 3 months had used anti osteoporosis drugs or affect the balance of calcium and phosphorus (such as bisphosphonates, calcitonin, estrogen, selective estrogen receptor modulators, parathyroid hormone, strontium salt, vitamin D, vitamin K2, calcium supplements, phosphorus preparation, phosphate binders, glucocorticoid hormone); or test the first dose within 14 days before taking any drugs; 8) there is a food, drug allergy or allergy that is determined by the researchers for clinical significance; 9) any special requirement for food and diet should not comply with the unifying diet; 10) screening for alcohol abuse within 1 years (currently has proof of alcoholism, 2 alcohol 1 times / day, drinking =150mL wine, beer or liquor, 360mL or 50ml) or alcohol breath test results are out of range (more than 5mg/100mL); 11) screening before the 1 years history of drug abuse, drug addiction or screening period of positive urine test; 12) smoking was still in the first 3 months, and more than 5 cigarettes were smoked daily; 13) in the first 3 months before the trial, the trial was used as a subject for any clinical trial; 14) test the first dose within 3 months before had blood or blood loss more than 400mL; 15) do not agree to avoid alcohol or caffeinated beverages within 24 hours before trial and during the trial period, or disagree to avoid strenuous exercise or disagree with other factors that affect the absorption, distribution, metabolism and excretion of drugs; 16) pregnant women or lactating women, or those with positive serum HCG, could not or did not follow the guidance of researchers, and adopt contraceptive methods approved by researchers during the study period; 17) self screening of male and female having childbearing intention for half a year; 18) the positive results were found in the serological examination (HBsAg, anti HCV, anti HIV, TP) during the screening period; 19) researchers think it is not suitable for participants in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood calcium;Blood phosphorus;Urinary calcium;PTH (1-84);PTH (1-34); | — |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure;heart rate;breathing;temperature;Routine blood test;Urine routine;Blood biochemistry;Blood pregnancy;electrocardiogram;Chest X ray examination;Abdominal B-ultrasound;Urine drug screening;Alcohol exhalation test;serological examination; | — |
Countries
China
Contacts
Public ContactLirui; Gaorui
Xiyuan Hospital of Chinese Academy of Chinese Medicine
Outcome results
None listed