OsteoporosisNCT00698984
Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomarkers of Bone Health
A study testing BONISTEIN(R) bone blend in people with Osteoporosis, run by dsm-firmenich Switzerland AG at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- BONISTEIN(R) bone blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2009
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
- Any condition which might interfere with absorption of the investigational product (e.g. malabsorption syndrome)
- Co-medication: Anticoagulants, parathyroid hormones, corticosteroids, thiazide diuretic
- Subjects who, during the previous 24 months, received a total fee payment greater than 5'000 USD for participation in biomedical research
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center - Osteoporosis Research Center
Omaha, Nebraska, 68131
About this study
Official title: Pilot Study To Investigate The Effect Of Bonistein(R) Bone Blend Containing Genistein, Polyunsaturated Fatty Acids (N-3 PUFAS) And Vitamins K1 And D3 On Bone Mineral Density (BMD), Bone Mineral Content (BMC) And Biomarkers Of Bone Health In Early Postmenopausal Women
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.
Read the detailed description
Osteoporosis is the most frequent disease of the skeletal system with approximately one third of all postmenopausal women being currently affected in the USA and in Europe. The role of nutrition in bone health has been increasingly recognized in the last couple of years. In particular nutrients such as isoflavones, vitamins D and K as well as polyunsaturated fatty acids (PUFA) have been implicate in bone health recently.
The DSM Nutritional Products Ltd product BONISTEIN(R) is a synthetic genistein. Its genistin aglycone purity is above 99 % and the appearance is a beige crystal.
In addition to the primary and secondary outcomes, body composition, genistein plasma levels, diet and physical activity are assessed.
- Conditions
- Osteoporosis
- Being tested
- BONISTEIN(R) bone blend, Placebo
- Keywords
- Soy Isoflavones, Bone Mineral Density, Bone Mineral Content, postmenopausal Women, Bone Markers, Bone Health, Phytoestrogens
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BONISTEIN(R) bone blendDietary supplement
2 Capsules per day over a period of 6 months
PlaceboDietary supplement
2 capsules per day over a period of 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 30 mg BONISTEIN(R) 150 ug Vitamin K1 800 IU Vitamin D3 1000 mg PUFA 500 mg Calcium Receives: Dietary Supplement: BONISTEIN(R) bone blend |
| 2 | Placebo comparator | 500 mg Calcium Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density/Content (BMD/BMC) at lumbar spine and femoral neck
Measured: Baseline and after 6 months
Secondary outcomes (1)
BMD/BMC on whole body, Ward's Triangle, total hip, and (inter)trochanter Bone resorption markers: DPD, NTX, RANKL/OPG Bone formation markers: bALP, OC, ucOC
Measured: Baseline and after 3 and 6 months (bone markers)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert P Heaney, MD, Principal investigator, Creighton University Medical Center - Osteoporosis Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698984
- Sponsor's protocol ID
- GEN/BLEND-06.06
- Status last verified
- Jan 2009
- First submitted
- 13 Jun 2008
- Last updated
- 16 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study To Investigate The Effect Of Bonistein(R) Bone Blend Containing Genistein, Polyunsaturated Fatty Acids (N-3 PUFAS) And Vitamins K1 And D3 On Bone Mineral Density (BMD), Bone Mineral Content (BMC) And Biomarkers Of Bone Health In Early Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00698984
- Acronym / sponsor ID
- GEN/BLEND-06.06
- Conditions
- Osteoporosis
- Keywords
- Soy Isoflavones, Bone Mineral Density, Bone Mineral Content, postmenopausal Women, Bone Markers, Bone Health, Phytoestrogens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 17 Jun 2008 (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.
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.
Detailed description
Osteoporosis is the most frequent disease of the skeletal system with approximately one third of all postmenopausal women being currently affected in the USA and in Europe. The role of nutrition in bone health has been increasingly recognized in the last couple of years. In particular nutrients such as isoflavones, vitamins D and K as well as polyunsaturated fatty acids (PUFA) have been implicate in bone health recently.
The DSM Nutritional Products Ltd product BONISTEIN(R) is a synthetic genistein. Its genistin aglycone purity is above 99 % and the appearance is a beige crystal.
In addition to the primary and secondary outcomes, body composition, genistein plasma levels, diet and physical activity are assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: BONISTEIN(R) bone blend30 mg BONISTEIN(R) 150 ug Vitamin K1 800 IU Vitamin D3 1000 mg PUFA 500 mg Calcium |
| 2 | Placebo comparator | Dietary Supplement: Placebo500 mg Calcium |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (28 listed)
- 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
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 |
|---|---|---|
| BONISTEIN(R) bone blend2 Capsules per day over a period of 6 months | Dietary supplement | 1 |
| Placebo2 capsules per day over a period of 6 months | Dietary supplement | 2 |
Primary outcome
Bone Mineral Density/Content (BMD/BMC) at lumbar spine and femoral neck
Time frame: Baseline and after 6 months
1 secondary outcome
BMD/BMC on whole body, Ward's Triangle, total hip, and (inter)trochanter Bone resorption markers: DPD, NTX, RANKL/OPG Bone formation markers: bALP, OC, ucOC
Time frame: Baseline and after 3 and 6 months (bone markers)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2009.
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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.
Robert P Heaney, MD principal investigator
Creighton University Medical Center - Osteoporosis Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BONISTEIN(R) bone blend in people with Osteoporosis, run by dsm-firmenich Switzerland AG at 1 site in United States.
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 11 inclusion and 28 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: finished, as of the sponsor's last update on 16 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density/Content (BMD/BMC) at lumbar spine and femoral neck (time frame: Baseline and after 6 months). 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 16 Jan 2009.