Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomar… (NCT00698984) | Clinical Trial Compass
CompletedNot Applicable
Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomarkers of Bone Health
United States70 participantsStarted 2007-01
Plain-language summary
The purpose of this study is to obtain information about the effect of a combination of genistein, PUFAs, vitamin K and D (BONISTEIN(R) bone blend) on bone health, determined as bone mass density/content and bone biomarkers after 6-months treatment in 70 healthy postmenopausal women. In addition, safety and tolerability will be investigated.
Who can participate
Age range
45 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female
* Age 45 (inclusive) to 55 years (inclusive)
* Race: Caucasian
* Non-smokers / Smokers up to 10 cigarettes/day
* Postmenopausal hormone status: 1-3 years since the last spontaneous menstrual bleeding and a follicle-stimulating hormone concentration (FSH) \>75 IU/ml and 17-estradiol (E2) of \< 20 ng/L
* Years since menopause between 1-3 years
* Natural menopause or total hysterectomy with bilateral salpingo-oophorectomy
* Subjects with E2 results within the inclusion criteria range will be assessed on an individual basis if FSH level is less than 75 IU/ml
* Assessed as age-related healthy, based on a pre-study examination including medical history, physical examination, ECG, vital signs and clinical laboratory. The examination will be performed by a MD at the study site within 1-2 months prior planned study start for the individual subject.
* Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.
* Ability to understand, speak, read and write the English language
Exclusion Criteria:
* T-score \< -2.5 at total hip and spine (either or both)
* Suspect lack of compliance
* BMI \> 30 or \< 21
* Use of HRT within the previous 6 months
* Use of any drug which might interfere with bone-metabolism (bisphosphate, estrogen receptor modulators, calcitonin) within the previous 12 months
* Systematic practice of high intensity exercise
* Vegetarian nutritio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone Mineral Density/Content (BMD/BMC) at lumbar spine and femoral neck