Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
420 participants
INTERVENTIONAL
2004-12-31
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In order to investigate the effect of isoflavone on bone mineral density (BMD) and in Taiwan women with postmenopausal osteopenia, a Taiwan Isoflavone Multicentric Enrollment Study (TIMS) is designed.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In order to investigate the effect of isoflavone on bone mineral density (BMD) and in Taiwan women with postmenopausal osteopenia, a Taiwan Isoflavone Multicentric Enrollment Study (TIMS) is designed. Included in the study will be Taiwanese, postmenopausal women aged \>45 and \< 65 years, menopaused for at least 12 months and less than 10 years. Three medical centers will participate and enroll 140 women in every center. Inclusion will be on the basis of a lumbar bone mineral density (BMD) lower than 1 SD compared with young age women (T score) by DXA. Women with prevalent fractures (any kind of fragility fracture, vertebral or nonvertebral fracture) are excluded as well as those presenting secondary osteoporosis or having been treated with medications that could affect bone metabolism. This study is designed as a 2-year, double-blind, placebo-controlled, two-arm, parallel group study that randomizes the women to the oral administration of 300 mg isoflavone aglycone/day or placebo. All patients receive a daily supplement of 600 mg calcium and 300U of Vit D3. The primary endpoint of the study is to evaluate the effect of isoflavone aglycone on BMD. The secondary endpoint of the study will be to evaluate the effect of Isoflavone aglycone on the metabolic indicators of osteoporosis, blood pressure, blood sugar and insulin level, insulin resistance (HOMA-IR), lipid profile, markers of arthrosclerosis (adiponectin and hsCRP), myocardial infarction rate, cardiovascular mortality, cerebrovascular accident rate, cerebrovascular mortality, all cause mortality and symptomatic relief of menopausal syndrome, BMD reading will be done concomitantly by 3 experts, e.g. one from each participating center. All blood test and urine examination will be done at one center for control of quality. The blood count, biochemistry (including: GOT, GPT, BUN, creatinine), mammography, and gynecological sonography (especially uterus) will be performed to monitor the side effects.
Power calculations have been based on the hypothesis that isoflavone-treated patients would get 2.5% benefit in BMD than placebo-treated patients in postmenopausal women. Statistical tests have been designed to have a power of 80%, with a type I error equal to 5%. This study should verify the hypothesis that isoflavone significantly increase the BMD in Asian postmenopausal osteopenic women.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Soy Isoflavone
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. The postmenopausal women aged \>45 and \< 65 years.
3. For those being done with hysterectomy and age between 50 and 60, with FSH \>40 IU/l and Estradiol \< 40 pg/ml.
4. Bone mineral density (BMD) of lumbar spine L2-L4 (AP view) lower than 1 SD compared with young age women (T score\<-1)
5. BMI, above 18.5kg/m2 and below 30 kg/m2
6. Willingness to comply with the protocol and signed the written Informed Consent.
Exclusion Criteria
2. Secondary osteoporosis, osteomalacia, Paget's disease of bone, multiple myeloma, or bone metastases.
3. Hormonal replacement therapy (HRT) or SERM within the previous 3 months
4. Phytoestrogen treatment within the previous 3 months
5. Fluoride treatment within the previous 6 months
6. Bisphosphate treatment within the previous 12 months
7. Calcitonin treatment within the previous 6 months
8. Any other treatment affecting the bone mineral density within the previous 6 months
9. Chronic systemic corticosteroid treatment within the previous 6 months
10. History of Gynecological cancer or breast cancer
11. Cervical smear class III or IV, according to the Bethesda system.
12. Undiagnosed vaginal bleeding.
13. Known or suspected estrogen-dependent tumors, fibroids or endometrial polyps
14. Significant or Pathological endometrial hyperplasia
15. Active major psychiatric disorders
16. Alcoholism or drug abuse
17. Known cardiovascular, cerebrovascular or peripheral vascular disorders (e.g. thrombophlebitis, thromboembolism)
18. Uncontrolled Diabetes with HbA1C \> 10%
19. Uncontrolled hypertension with blood pressure \> 180/100 mmHg
20. Uncontrolled hypothyroidism
21. Any renal disease with serum creatinine \> 2mg/dl
22. Abnormal liver function with S-ALT and S-AST values\> 2-fold upper limits
45 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Taiwan Biotech Co., Ltd.
INDUSTRY
Genovate Biotechnology Co., Ltd.,
INDUSTRY
National Health Research Institutes, Taiwan
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tong-Yuan Tai, MD & PHD
Role: PRINCIPAL_INVESTIGATOR
NHRI
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Taiwan University Hospital
Taipei, Taipei, Taiwan
Chang-hua Christian Hospital
Chang-hua, , Taiwan
National Cheng-Kung University Hospital
Tainan City, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Keh-Sung Tsai, MD &PHD
Role: primary
Shih-Te Tu, MD
Role: primary
Jin-Shang Wu, MD
Role: primary
Chih-Hsing Wu, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GE-PP02
Identifier Type: -
Identifier Source: org_study_id
NCT00154908
Identifier Type: -
Identifier Source: nct_alias