Status:
UNKNOWN
A Taiwan Isoflavone Multicenter Study (TIMS)
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
Taiwan Biotech Co., Ltd.
Genovate Biotechnology Co., Ltd.,
Conditions:
Low Bone Density
Osteopenia
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief Summary
Consumption of soy-based foods is associated with a number of health benefits, including lower risk of cardiovascular disease, breast and prostate cancer, attenuated menopausal symptoms and prevention...
Detailed Description
Consumption of soy-based foods is associated with a number of health benefits, including lower risk of cardiovascular disease, breast and prostate cancer, attenuated menopausal symptoms and prevention...
Eligibility Criteria
Inclusion
- The postmenopausal women who menopaused for at least 12 months and less than 10 years.
- The postmenopausal women aged \>45 and \< 65 years.
- For those being done with hysterectomy and age between 50 and 60, with FSH \>40 IU/l and Estradiol \< 40 pg/ml.
- Bone mineral density (BMD) of lumbar spine L2-L4 (AP view) lower than 1 SD compared with young age women (T score\<-1)
- BMI, above 18.5kg/m2 and below 30 kg/m2
- Willingness to comply with the protocol and signed the written Informed Consent.
Exclusion
- Any prevalent vertebral, hip or wrist fractures.
- Secondary osteoporosis, osteomalacia, Paget's disease of bone, multiple myeloma, or bone metastases.
- Hormonal replacement therapy (HRT) or SERM within the previous 3 months
- Phytoestrogen treatment within the previous 3 months
- Fluoride treatment within the previous 6 months
- Bisphosphate treatment within the previous 12 months
- Calcitonin treatment within the previous 6 months
- Any other treatment affecting the bone mineral density within the previous 6 months
- Chronic systemic corticosteroid treatment within the previous 6 months
- History of Gynecological cancer or breast cancer
- Cervical smear class III or IV, according to the Bethesda system.
- Undiagnosed vaginal bleeding.
- Known or suspected estrogen-dependent tumors, fibroids or endometrial polyps
- Significant or Pathological endometrial hyperplasia
- Active major psychiatric disorders
- Alcoholism or drug abuse
- Known cardiovascular, cerebrovascular or peripheral vascular disorders (e.g. thrombophlebitis, thromboembolism)
- Uncontrolled Diabetes with HbA1C \> 10%
- Uncontrolled hypertension with blood pressure \> 180/100 mmHg
- Uncontrolled hypothyroidism
- Any renal disease with serum creatinine \> 2mg/dl
- Abnormal liver function with S-ALT and S-AST values\> 2-fold upper limits
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00262184
Start Date
December 1 2004
End Date
December 1 2007
Last Update
December 6 2005
Active Locations (3)
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1
National Taiwan University Hospital
Taipei, Taipei, Taiwan, 100
2
Chang-hua Christian Hospital
Chang-hua, Taiwan, 500
3
National Cheng-Kung University Hospital
Tainan, Taiwan, 700