A Taiwan Isoflavone Multicenter Study (TIMS)

Osteopenia Clinical Trial

Official title:

A Taiwan Isoflavone Multicenter Study (TIMS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00262184
• Other study ID #: GE-PP02
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2005
• Last updated: December 5, 2005
• Start date: December 2004
• Est. completion date: December 2007

Study information

• Verified date: December 2005
• Source: National Health Research Institutes, Taiwan
• Contact: Ching-I Chang, MS
• Phone: 886-02-26534401
• Email: cichang[@]nhri.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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 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. 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.

Other known NCT identifiers

• NCT00154908

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Low Bone Density
• Osteopenia

Intervention

Drug:
• Soy Isoflavone

Locations

Country	Name	City	State
Taiwan	Chang-hua Christian Hospital	Chang-hua
Taiwan	National Cheng-Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Genovate Biotechnology Co., Ltd.,, Taiwan Biotech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMD change
Secondary	Lipid profile