Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the E… (NCT00663104) | Clinical Trial Compass
TerminatedPhase 3
Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause
Germany126 participantsStarted 2008-04
Plain-language summary
The aim of the study is to compare the effect of a progressive, periodized exercise training designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined effect of exercise and "phytoestrogen" (cimicifuga racemosa; CR). After randomization, 84 females 1-3 year postmenopausal with no medication or illness affecting bone metabolism exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control. Three group training sessions/week will be performed in the EG. Both groups will be individually supplemented with calcium and Vit-D (cholecalciferol).
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:
* 1-3 years early postmenopausal
* Caucasian race
Exclusion Criteria:
* CHD-diseases
* thrombosis, embolism
* fractures at lumbar spine or hip
* secondary osteoporosis
* hyperparathyroidism
* medication, diseases with impact on muscle or bone
* cancer and hormone derived malign diseases
* weight reduction of \> 5 kg during the last 6 months
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
Timeframe: baseline, 12 month
Trial details
NCT IDNCT00663104
SponsorUniversity of Erlangen-Nürnberg Medical School