NCT00202956

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Osteoporosis

Interventions

BugusanDRUG

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Huey-Herng Sheu

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huey-Herng Sheu

CONTACT

8860402359-2525whhsheu@vghtc.gov.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2004

Study Completion

May 1, 2005

Last Updated

September 20, 2005

Record last verified: 2005-09

Locations

TW(1)