Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomarkers of Bone Health

Completed · Not applicable · Has a placebo group

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID: NCT00698984
Run by: dsm-firmenich Switzerland AG
People needed: 70
Starts: 2007-01-01
Expected to finish: 2009-01-01
Last updated by the study team: 2009-01-16

Who can join

Age: 45 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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 nutrition or any other extreme dietary habits
Use of dietary supplements while on study, except multi vitamin. No "wash out" period for supplements - must stop before run-in period and refrain until the end of the study.
Participant in any other study or donation of blood during the last 30 days before start of each dosing phase (T0).
Total genistein blood concentrations of > 100 ng/ml measured at pre-study examination
Known hypersensitivity or allergy to soy, purified isoflavones, peanuts, fish, and/or genistein.
Hepatitis screen (serology) positive or not performed
Drug screen positive or not performed (at least amphetamines, benzodiazepines, cannabinoides, opiates).
Subjects on a weight reduction program or a medically supervised diet
Unexplained weight loss or weight gain of more than 5 kg in the three months prior to the study
History of liver or pancreas diseases
Cardiovascular diseases, even AV-block I0 (PQ time > 220 ms) and QTc time > 450 ms
History of breast cancer, endometrial cancer and other malignancy except basal and squamous cell skin cancer
History of thromboembolism or deep venous thrombosis
Any fractures within one year except for fingers, toes and facial bones
Subjects with susceptibility for fractures as a history of being a faller
Endometrial thickness > 6 mm
Endometrial polyps
Untreated hypo- or hyperthyroidism
Insulin-dependent diabetes mellitus, Crohn's Disease, Cushing Disease etc.

Where it is running

Creighton University Medical Center - Osteoporosis Research Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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