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

Taichung Veterans General Hospital

Status and phase: Unknown; Phase 2

Conditions: Osteoporosis

Treatments: Drug: Bugusan

Study type: Interventional

Funder types: Other

Identifiers

NCT00202956

JL-HM-01-01

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind