AzTrials
AzTrials

Bone DiseasesPhase 3NCT00663104

Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

A Phase 3 study testing exercise and exercise + cimicifuga racemosa in people with Bone Diseases and Metabolic Syndrome X, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 45 to 55 years, women onlyHealthy volunteers can take part
What is being tested?
exercise and exercise + cimicifuga racemosa
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
1 siteGermany
Study dates
Apr 2008to Nov 2009
Phase
Phase 3
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

  • 1-3 years early postmenopausal
  • Caucasian race

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Institute of Medical Physics

    Erlangen, 91052

Other trials in Germany

About this study

Official title: Effect of Exercise and Exercise + Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

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).

Being tested
exercise, exercise + cimicifuga racemosa, wellness control, placebo
Keywords
early menopause, exercise, phytoestrogen, bone, CHD-risk factors
Medical subject headings
Bone Diseases, Metabolic Syndrome, Coronary Disease, Primary Ovarian Insufficiency, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exerciseBehavioural

    exercise: 3 joint sessions/week for 12 months

  • exercise + cimicifuga racemosaBehavioural

    exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)

  • wellness control, placeboBehavioural

    2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo

Study groups in NCT00663104
Study groupRoleWhat they receive
1Active comparatorexercise (3 sessions/week)
Receives: Behavioral: exercise
2Active comparatorexercise and "phytoestrogen" (cimicifuga racemosa)
Receives: Behavioral: exercise + cimicifuga racemosa
3Placebo comparatorwellness control, placebo
Receives: Behavioral: wellness control, placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone Mineral Density

    Measured: baseline, 12 month

Secondary outcomes (5)

  1. body composition

    Measured: baseline, 12 month

  2. blood lipids, glucose

    Measured: baseline, 12 month

  3. blood pressure

    Measured: baseline, 12 month

  4. 10 year CHD-risk

    Measured: baseline, 12 months

  5. menopausal complaints

    Measured: baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJun 2009
  4. Study completionNov 2009

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00663104
Sponsor's protocol ID
OFZ-Trace
Status last verified
May 2015
First submitted
21 Apr 2008
Last updated
28 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention Study (EFOPS). Arch Intern Med. 2004 May 24;164(10):1084-91. doi: 10.1001/archinte.164.10.1084.

    PubMed 15159265

  • von Stengel S, Kemmler W, Kalender WA, Engelke K, Lauber D. Differential effects of strength versus power training on bone mineral density in postmenopausal women: a 2-year longitudinal study. Br J Sports Med. 2007 Oct;41(10):649-55; discussion 655. doi: 10.1136/bjsm.2006.033480. Epub 2007 Jun 5.

    PubMed 17550916

  • Kemmler W, von Stengel S, Weineck J, Lauber D, Kalender W, Engelke K. Exercise effects on menopausal risk factors of early postmenopausal women: 3-yr Erlangen fitness osteoporosis prevention study results. Med Sci Sports Exerc. 2005 Feb;37(2):194-203. doi: 10.1249/01.mss.0000152678.20239.76.

    PubMed 15692313

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exercise and exercise + cimicifuga racemosa in people with Bone Diseases and Metabolic Syndrome X, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 May 2015. 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 Germany. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

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 (time frame: baseline, 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00663104, which also lists 3 linked publications.

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 28 May 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in