A Taiwan Isoflavone Multicenter Study (TIMS)

• Status: Unknown status
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

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 of bone loss with age.

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Genovate Biotechnology Co., Ltd.,; Taiwan Biotech Co., Ltd.

Criteria

Inclusion Criteria:

1. The postmenopausal women who menopaused for at least 12 months and less than 10 years.

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:

1. Any prevalent vertebral, hip or wrist fractures.

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