Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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;

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method