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

Primary Purpose

Osteoporosis

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Bugusan
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)Female

Inclusion Criteria: 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; Patients have bone mineral density <-2.5 SD of T score at the lumbar spine (L2-L4); All patients must sign the informed consent form (ICF) prior to the trial. Exclusion Criteria: Any X-ray film that documents substantial scoliosis, or spinal secondary osteoporosis; Any X-ray film that documents bone fracture within 3 month prior to the trial. Medication such as estrogen, bisphosphonates, calcitonin, fluoride, glucocorticoids, ipriflavone intake within 3 weeks prior to the trial; Use of other Chinese medicine within 2 weeks prior to the trial; Patients with significant renal function impairment (Creatinine>2mg/dl) and liver function impairment (AST and ALT > 2 x the upper limit of normal range); Patients have laboratory test abnormality, which in the investigator's opinion might confound the study; Patients have severe cardiac disease, e.g. unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification III and IV); Patients have life threatening disease; Patients are allergic to any of the composition of Chinese medicine; Significant concomitant disease or medical history that could interfere with the study as judged by the investigator;

Sites / Locations

  • Taichung Veterans General HospitalRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00202956
Brief Title
Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bugusan

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria: 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; Patients have bone mineral density <-2.5 SD of T score at the lumbar spine (L2-L4); All patients must sign the informed consent form (ICF) prior to the trial. Exclusion Criteria: Any X-ray film that documents substantial scoliosis, or spinal secondary osteoporosis; Any X-ray film that documents bone fracture within 3 month prior to the trial. Medication such as estrogen, bisphosphonates, calcitonin, fluoride, glucocorticoids, ipriflavone intake within 3 weeks prior to the trial; Use of other Chinese medicine within 2 weeks prior to the trial; Patients with significant renal function impairment (Creatinine>2mg/dl) and liver function impairment (AST and ALT > 2 x the upper limit of normal range); Patients have laboratory test abnormality, which in the investigator's opinion might confound the study; Patients have severe cardiac disease, e.g. unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification III and IV); Patients have life threatening disease; Patients are allergic to any of the composition of Chinese medicine; Significant concomitant disease or medical history that could interfere with the study as judged by the investigator;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huey-Herng Sheu
Phone
8860402359-2525
Ext
4004
Email
whhsheu@vghtc.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huey-Herng Sheu
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huey-Herng Sheu, Doctor
Phone
886-4-2359-2525
Ext
4004
Email
whhsheu@vghtc.gov.tw
First Name & Middle Initial & Last Name & Degree
Huey-Herng Sheu, Doctor

12. IPD Sharing Statement

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

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