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UNKNOWNPHASE2

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.

NCT00202956•Taichung Veterans General Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - 75 years

Sex

FEMALE

Healthy Volunteers

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;

Locations (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Key Dates

Start Date

June 1, 2004

Completion Date

May 1, 2005

Last Updated

September 20, 2005

Conditions

Osteoporosis

Interventions

Bugusan

DRUG

Contacts

Huey-Herng Sheu

CONTACT

8860402359-2525 whhsheu@vghtc.gov.tw

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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