Trial record 14 of 119 for:    Open Studies | "Bone Density"

A Taiwan Isoflavone Multicenter Study (TIMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by National Health Research Institutes, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Taiwan Biotech Co., Ltd.
Genovate Biotechnology Co., Ltd.,
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00262184
First received: December 5, 2005
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Low Bone Density
Osteopenia
Drug: Soy Isoflavone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Taiwan Isoflavone Multicenter Study (TIMS)

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • BMD change

Secondary Outcome Measures:
  • Lipid profile

Estimated Enrollment: 420
Study Start Date: December 2004
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262184

Contacts
Contact: Ching-I Chang, MS 886-02-26534401 ext 27306 cichang@nhri.org.tw

Locations
Taiwan
Chang-hua Christian Hospital Recruiting
Chang-hua, Taiwan, 500
Contact: Shih-Te Tu, MD    886-4-7009198    10836@cch.org.tw   
National Cheng-Kung University Hospital Recruiting
Tainan, Taiwan, 700
Contact: Jin-Shang Wu, MD    886-6-3028119    jins@mail.ncku.edu.tw   
Contact: Chih-Hsing Wu, MD    886-6-3028119    paulo@mail.ncku.edu.tw   
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Keh-Sung Tsai, MD &PHD    886-02-23562149    kstsaimd@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Taiwan Biotech Co., Ltd.
Genovate Biotechnology Co., Ltd.,
Investigators
Principal Investigator: Tong-Yuan Tai, MD & PHD NHRI
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00262184     History of Changes
Obsolete Identifiers: NCT00154908
Other Study ID Numbers: GE-PP02
Study First Received: December 5, 2005
Last Updated: December 5, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
Post-Menopausal osteopenia

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 22, 2014