NCT00698984

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 16, 2009

Status Verified

January 1, 2009

Enrollment Period

2 years

First QC Date

June 13, 2008

Last Update Submit

January 15, 2009

Conditions

Osteoporosis

Keywords

Soy Isoflavones, Bone Mineral Density, Bone Mineral Content, postmenopausal Women, Bone Markers, Bone Health, Phytoestrogens

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density/Content (BMD/BMC) at lumbar spine and femoral neck

    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

    Baseline and after 3 and 6 months (bone markers)

Study Arms (2)

1

ACTIVE COMPARATOR

30 mg BONISTEIN(R) 150 ug Vitamin K1 800 IU Vitamin D3 1000 mg PUFA 500 mg Calcium

Dietary Supplement: BONISTEIN(R) bone blend

2

PLACEBO COMPARATOR

500 mg Calcium

Dietary Supplement: Placebo

Interventions

BONISTEIN(R) bone blendDIETARY_SUPPLEMENT

2 Capsules per day over a period of 6 months

1
PlaceboDIETARY_SUPPLEMENT

2 capsules per day over a period of 6 months

2

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University Medical Center - Osteoporosis Research Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Robert P Heaney, MD

    Creighton University Medical Center - Osteoporosis Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 17, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 16, 2009

Record last verified: 2009-01

Locations

US(1)