Single and Five-Week Oral Dose Toxicity Studies of Calcitriol and Alendronate Mixtures in Rats = Single and Five-Week Oral Dose Toxicity Studies of Calcitriol and Alendronate Mixtures in Rats

다국어 초록 (Multilingual Abstract)

The purpose of this study was to assess the single and 5 week oral dose toxicity of<br/>
calcitriol and alendronate combination (1 : 10,000) treatment for osteoporosis or Paget's disease in<br/>
male and female rats. In single dose oral toxicity study, the values of LD50 of calcitriol and alendronate<br/>
mixture were 750.075 mg/kg in male rats and 775.0775 mg/kg in female rats, respectively.<br/>
Body weight and food consumption were continuously increased after adminstration of calcitriol and<br/>
alendronate mixtures, and there was no significant changes in body weight and food consumption in<br/>
all groups. In five-week oral toxicity study of calcitriol and alendronate mixture at a dose of 0.2 μg +<br/>
2 mg, 1 μg + 10 mg, 5 μg + 50 mg and 25 μg + 250 mg, respectively, there was no mortality,<br/>
abnormal behavior and appearance in all groups throughout the administration period (5 weeks) and<br/>
recovery period (2 weeks). Dose-dependent changes in parameters of urinalysis and hematological<br/>
analysis were not observed in male and female rats treated with calcitriol and alendronate mixtures.<br/>
All the values of the parameters appeared to be in the normal range. These data indicate that both<br/>
calcitriol and alendronate are drugs having low toxicity in rats. NOAEL of calcitriol and alendronate<br/>
mixtures were 50.005 mg/kg in 5-week oral toxicity.

목차 (Table of Contents)

• ABSTRACT
  
• INTRODUCTION
  
• MATERIALS AND METHODS
  
• RESULTS
  
• DISCUSSION
  
• ACKNOWLEDGEMENTS
  
• REFERENCES