Low Bone DensityNCT00262184
A Taiwan Isoflavone Multicenter Study (TIMS)
A study testing Soy Isoflavone in people with Low Bone Density and Osteopenia, run by National Health Research Institutes, Taiwan at 3 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Low Bone Density, Osteopenia
- What is being tested?
- Soy Isoflavone
- How many people
- 420 participants
- Where
- 3 sitesTaiwan
- Study dates
- Dec 2004to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
- Alcoholism or drug abuse
- Known cardiovascular, cerebrovascular or peripheral vascular disorders (e.g. thrombophlebitis, thromboembolism)
- Uncontrolled Diabetes with HbA1C > 10%
- Uncontrolled hypertension with blood pressure > 180/100 mmHg
- Uncontrolled hypothyroidism
- Any renal disease with serum creatinine > 2mg/dl
- Abnormal liver function with S-ALT and S-AST values> 2-fold upper limits
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites, 3 recruiting
- Recruiting
Chang-hua Christian Hospital
Chang-hua, 500
Shih-Te Tu, MD, 886-4-7009198, 10836@cch.org.tw
- Recruiting
National Cheng-Kung University Hospital
Tainan, 700
Jin-Shang Wu, MD, 886-6-3028119, jins@mail.ncku.edu.tw
Chih-Hsing Wu, MD, 886-6-3028119, paulo@mail.ncku.edu.tw
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 100
Keh-Sung Tsai, MD &PHD, 886-02-23562149, kstsaimd@ha.mc.ntu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Low Bone Density, Osteopenia
- Being tested
- Soy Isoflavone
- Keywords
- Post-Menopausal osteopenia
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy IsoflavoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD change
Secondary outcomes (1)
Lipid profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startDec 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Bone DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 420 participants
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Biotech Co., Ltd., Genovate Biotechnology Co., Ltd.,
- Investigators
- Tong-Yuan Tai, MD & PHD, Principal investigator, NHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262184
- Sponsor's protocol ID
- GE-PP02
- Status last verified
- Dec 2005
- First submitted
- 5 Dec 2005
- Last updated
- 6 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Taiwan Isoflavone Multicenter Study (TIMS)
- ClinicalTrials.gov ID
- NCT00262184
- Acronym / sponsor ID
- GE-PP02
- Conditions
- Low Bone Density, Osteopenia
- Keywords
- Post-Menopausal osteopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Taiwan Biotech Co., Ltd., Genovate Biotechnology Co., Ltd.,
- Study start
- Dec 2004
- Study completion
- Dec 2007
- First posted
- 6 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy Isoflavone | Drug | – |
Primary outcome
BMD change
1 secondary outcome
Lipid profile
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tong-Yuan Tai, MD & PHD principal investigator
NHRI
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy Isoflavone in people with Low Bone Density and Osteopenia, run by National Health Research Institutes, Taiwan at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-I Chang, MS (886-02-26534401 ext. 27306, cichang@nhri.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMD change. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2005.