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Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.
This study is currently recruiting participants.
Verified by Taichung Veterans General Hospital, September 2005
First Received: September 12, 2005   No Changes Posted
Sponsored by: Taichung Veterans General Hospital
Information provided by: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00202956
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: Bugusan
Phase II

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Taichung Veterans General Hospital:

Study Start Date: June 2004
Estimated Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202956

Contacts
Contact: Huey-Herng Sheu 8860402359-2525 ext 4004 whhsheu@vghtc.gov.tw

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
Contact: Huey-Herng Sheu, Doctor     886-4-2359-2525 ext 4004     whhsheu@vghtc.gov.tw    
Principal Investigator: Huey-Herng Sheu, Doctor            
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: Huey-Herng Sheu Taichung Veterans General Hospital
  More Information

No publications provided

Study ID Numbers: JL-HM-01-01
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00202956     History of Changes
Health Authority: Taiwan: Department of Health

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009