OsteoporosisPhase 2NCT00202956
Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.
A Phase 2 study testing Bugusan in people with Osteoporosis, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Bugusan
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Jun 2004to May 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung
Huey-Herng Sheu, Doctor, 886-4-2359-2525 ext. 4004, whhsheu@vghtc.gov.tw
Huey-Herng Sheu, Doctor
About this 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.
The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Bugusan
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BugusanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Huey-Herng Sheu, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202956
- Sponsor's protocol ID
- JL-HM-01-01
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00202956
- Acronym / sponsor ID
- JL-HM-01-01
- Conditions
- Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- May 2005
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bugusan | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huey-Herng Sheu principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bugusan in people with Osteoporosis, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huey-Herng Sheu (8860402359-2525 ext. 4004, whhsheu@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2005.