A Taiwan Isoflavone Multicenter Study (TIMS)

December 5, 2005 updated by: National Health Research Institutes, Taiwan

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Chang-hua, Taiwan, 500
        • Recruiting
        • Chang-Hua Christian Hospital
        • Contact:
      • Tainan, Taiwan, 700
        • Recruiting
        • National Cheng-Kung University Hospital
        • Contact:
        • Contact:
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
BMD change

Secondary Outcome Measures

Outcome Measure
Lipid profile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Research Institutes, Taiwan

Collaborators

Genovate Biotechnology Co., Ltd.,
Taiwan Biotech Co., Ltd.

Investigators

  • Principal Investigator: Tong-Yuan Tai, MD & PHD, NHRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

December 5, 2005

First Submitted That Met QC Criteria

December 5, 2005

First Posted (Estimate)

December 6, 2005

Study Record Updates

Last Update Posted (Estimate)

December 6, 2005

Last Update Submitted That Met QC Criteria

December 5, 2005

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE-PP02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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