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

Osteoporosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00202956
• Other study ID #: JL-HM-01-01
• Status: Recruiting
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: June 2004
• Est. completion date: May 2005

Study information

• Verified date: September 2005
• Source: Taichung Veterans General Hospital
• Contact: Huey-Herng Sheu
• Phone: 8860402359-2525
• Email: whhsheu[@]vghtc.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: May 2005
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Bugusan

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan,