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

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects on Biomarkers and Safety of Bugusan (BGS) in Postmenopausal Patients With Osteoporosis.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00202956

Enrollment

Unknown

Registered

2005-09-20

Start date

2004-06-30

Completion date

2005-05-31

Last updated

2005-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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.

Interventions

DRUGBugusan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 75 Years

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;

Countries

Taiwan

Contacts

Primary ContactHuey-Herng Sheu

whhsheu@vghtc.gov.tw8860402359-2525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026