A Taiwan Isoflavone Multicenter Study (TIMS)

NCT00262184 | Unknown

• 1 other identifier: GE-PP02
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Low Bone Density; Osteopenia

Keywords

Post-Menopausal osteopenia

Outcome Measures

Primary Outcomes (1)

• BMD change

Secondary Outcomes (1)

• Lipid profile

Interventions

Soy Isoflavone DRUG

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Taiwan Biotech Co., Ltd.: collaborator
• Genovate Biotechnology Co., Ltd.,: collaborator

Study Sites (3)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

RECRUITING

Chang-hua Christian Hospital

Chang-hua, 500, Taiwan

RECRUITING

National Cheng-Kung University Hospital

Tainan, 700, Taiwan

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Tong-Yuan Tai, MD & PHD

  NHRI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-I Chang, MS

CONTACT

886-02-26534401; cichang@nhri.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2005
• First Posted: December 6, 2005
• Study Start: December 1, 2004
• Study Completion: December 1, 2007
• Last Updated: December 6, 2005

Record last verified: 2005-12

Locations

TW (3)