Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoporosis
- Sponsor
- TNO
- Enrollment
- 300
- Locations
- 3
- Primary Endpoint
- Bone mineral density of total body and lumbar spine (DXA)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to HRT for preventing bone loss during the menopausal transition. We investigated whether one-year consumption of isoflavone-enriched foods affected bone mineral density, bone metabolism and hormonal status in early postmenopausal women in a randomized double-blind, placebo controlled parallel multi-centre trial.
Detailed Description
Two hundred and thirty-seven healthy early post-menopausal women (age 53 ± 3 y; time since last menses 33 ± 15 months) consumed isoflavone-enriched foods providing a mean daily intake of 110 mg isoflavone aglycones or control products for 1 yr whilst continuing their habitual diet and lifestyle. Outcome measures included bone mineral density of lumbar spine and total body, markers for bone formation and bone resorption, hormones, isoflavones in plasma and urine, safety parameters and reporting of adverse events.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy as assessed by the:
- •health and lifestyle questionnaire
- •physical examination
- •results of the pre-study laboratory tests
- •Caucasian women
- •Postmenopausal (≥12 - ≤60 months since last menses), determined by
- •interview
- •FSH level ≥ 20 IU/l
- •Body Mass Index (BMI) ≥22 - ≤29 kg/m2
- •Voluntary participation
Exclusion Criteria
- •Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study
- •Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of products
- •Osteoporosis, determined by
- •Questionnaire (spontaneous bone fractures, use of medication to treat osteoporosis)
- •DXA scans of the lumbar spine between day -14 and day 1 of the study; exclusion threshold is set at -2z score of BMD
- •Severe scoliosis (curvature of the spine) that could interfere with the ability of the subject to go through the DXA scanning procedure and/or with a correct reading of the DXA scans
- •Having a history of medical or surgical events that may significantly affect the study outcome, including:
- •surgical menopause (including hysterectomy)
- •antecedents and high familiar incidence of breast and/or endometrial cancer
- •gastrointestinal disease (Crohn's, short bowel syndrome, coeliac disease, gastroenteritis episodes the month before the start of the study)
Outcomes
Primary Outcomes
Bone mineral density of total body and lumbar spine (DXA)
Secondary Outcomes
- Blood and urine markers for bone formation (ALP, PINP) and bone resorption (DPD, PYD)
- Hormones (estradiol, FSH, LH, SHBG)