Status:
UNKNOWN
Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.
Lead Sponsor:
Taichung Veterans General Hospital
Conditions:
Osteoporosis
Eligibility:
FEMALE
45-75 years
Phase:
PHASE2
Brief Summary
The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis.
Detailed Description
The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis by a study of Randomized, Double Blind, Placebo-Controlled, Parallel Group.
Eligibility Criteria
Inclusion
- Postmenopausal women between the ages of 45 and 75 years with a natural menopause ≧ 6 months and serum E2 values \< 20 pg/ml, serum FSH values ≧ 25 mIU/mL;
- Patients have bone mineral density \<-2.5 SD of T score at the lumbar spine (L2-L4);
- All patients must sign the informed consent form (ICF) prior to the trial.
Exclusion
- Any X-ray film that documents substantial scoliosis, or spinal secondary osteoporosis;
- Any X-ray film that documents bone fracture within 3 month prior to the trial.
- Medication such as estrogen, bisphosphonates, calcitonin, fluoride, glucocorticoids, ipriflavone intake within 3 weeks prior to the trial;
- Use of other Chinese medicine within 2 weeks prior to the trial;
- Patients with significant renal function impairment (Creatinine\>2mg/dl) and liver function impairment (AST and ALT \> 2 x the upper limit of normal range);
- Patients have laboratory test abnormality, which in the investigator's opinion might confound the study;
- Patients have severe cardiac disease, e.g. unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification III and IV);
- Patients have life threatening disease;
- Patients are allergic to any of the composition of Chinese medicine;
- Significant concomitant disease or medical history that could interfere with the study as judged by the investigator;
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00202956
Start Date
June 1 2004
End Date
May 1 2005
Last Update
September 20 2005
Active Locations (1)
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1
Taichung Veterans General Hospital
Taichung, Taiwan