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

• Status: Unknown status
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis.

• Phase: Phase 2

Details

• Lead Sponsor: Taichung Veterans General Hospital

Criteria

Inclusion Criteria:

1. 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;

2. Patients have bone mineral density <-2.5 SD of T score at the lumbar spine (L2-L4);

3. All patients must sign the informed consent form (ICF) prior to the trial.

Exclusion Criteria:

1. Any X-ray film that documents substantial scoliosis, or spinal secondary osteoporosis;

2. Any X-ray film that documents bone fracture within 3 month prior to the trial.

3. Medication such as estrogen, bisphosphonates, calcitonin, fluoride, glucocorticoids, ipriflavone intake within 3 weeks prior to the trial;

4. Use of other Chinese medicine within 2 weeks prior to the trial;

5. Patients with significant renal function impairment (Creatinine>2mg/dl) and liver function impairment (AST and ALT > 2 x the upper limit of normal range);

6. Patients have laboratory test abnormality, which in the investigator's opinion might confound the study;

7. Patients have severe cardiac disease, e.g. unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification III and IV);

8. Patients have life threatening disease;

9. Patients are allergic to any of the composition of Chinese medicine;

10. Significant concomitant disease or medical history that could interfere with the study as judged by the investigator;