OsteoporosisEFOPSNCT01177761
The Erlangen Fitness and Prevention Study (EFOPS).
A study testing physical exercise in people with Osteoporosis and Osteopenia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The study determines the long-term effect of exercise on osteoporotic fracture risk. Since actually no controlled supervised exercise study exceeds the time frame of 4 years, knowledge concerning the long-term effect of exercise on fractures and fracture-risk factors is scarce. Read more about this study
- Who is it for?
- Ages 48 years and older, women only
- Conditions the study is for
- Osteoporosis, Osteopenia, Early Postmenopause
- What is being tested?
- physical exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Oct 1998to Nov 2023
- 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 48 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants of the EFOPS-study,
- 12 years of exercise training according to the EFOPS-protocol (exercise).
Who cannot join
- medication and diseases affecting bone metabolism,
- inflammable diseases,
- cardiovascular diseases,
- start of relevant physical exercise programs beside the EFOPS protocol.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, Bavaria, 91052
About this study
Official title: Effects of Exercise on Fracture Risk, Bone Mineral Density and Falls in Postmenopausal Women. The Long-term Erlangen Fitness and Prevention Study.
The study determines the long-term effect of exercise on osteoporotic fracture risk. Since actually no controlled supervised exercise study exceeds the time frame of 4 years, knowledge concerning the long-term effect of exercise on fractures and fracture-risk factors is scarce. Within the Erlanger Fitness and Osteoporosis Study (EFOPS, an ongoing controlled exercise study with currently 16 years of supervised exercise with 45-50 osteopenic, early-postmenopausal women in exercise and sedentary control group each, the investigators therefore focus on overall-fractures, Bone Mineral Density and falls.
- Conditions
- Osteoporosis, Osteopenia, Early Postmenopause
- Being tested
- physical exercise
- Keywords
- Osteoporosis, exercise, fractures, Bone Mineral Density, CHD-risk
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Motor Activity, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseProcedure or surgery
Two sessions/week, 50 weeks/year over 12 years of high intensity exercise training
| Study group | Role | What they receive |
|---|---|---|
| exercise | Active comparator | endurance,balance, power, resistance type exercise Receives: Procedure: physical exercise |
| sedentary control | No intervention | Subjects were instructed to do not relevantly change their lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall-fractures (low-trauma)
As assessed by questionnaire and structured interview
Measured: 16 year follow-up
Bone Mineral Density at Lumbar Spine and Proximal Femur
As assessed by Dual-Energy X-ray Absorptiometry (DEXA)
Measured: 16 year follow-up
Secondary outcomes (2)
10-year coronary heart disease (CHD) risk
As assessed by Framingham Risk Factor Calculator according to Wilson.
Measured: 16 year follow-up
Metabolic Syndrome Z-Score
Metabolic Syndrome Z-Score Index according to Johnson
Measured: 16 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startOct 1998
- Primary completionNov 2023
- Study completionNov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Behinderten- und Versehrten-Sportverband Bayern e.V., Netzwerk Knochengesundheit e.V.
- Responsible party
- Principal investigator, Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
- Investigators
- Willi A Kalender, PHD, MD, Study chair, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177761
- Sponsor's protocol ID
- OFZ-EFOPS
- Acronym
- EFOPS
- Status last verified
- Nov 2023
- First submitted
- 6 Aug 2010
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Kemmler W, von Stengel S, Bebenek M, Engelke K, Hentschke C, Kalender WA. Exercise and fractures in postmenopausal women: 12-year results of the Erlangen Fitness and Osteoporosis Prevention Study (EFOPS). Osteoporos Int. 2012 Apr;23(4):1267-76. doi: 10.1007/s00198-011-1663-5. Epub 2011 May 28.
PubMed 21625881Kemmler W, von Stengel S. Dose-response effect of exercise frequency on bone mineral density in post-menopausal, osteopenic women. Scand J Med Sci Sports. 2014 Jun;24(3):526-34. doi: 10.1111/sms.12024. Epub 2012 Nov 28.
PubMed 23190199Engelke K, Kemmler W, Lauber D, Beeskow C, Pintag R, Kalender WA. Exercise maintains bone density at spine and hip EFOPS: a 3-year longitudinal study in early postmenopausal women. Osteoporos Int. 2006 Jan;17(1):133-42. doi: 10.1007/s00198-005-1938-9. Epub 2005 Aug 12.
PubMed 16096715Kemmler W, Engelke K, von Stengel S, Weineck J, Lauber D, Kalender WA. Long-term four-year exercise has a positive effect on menopausal risk factors: the Erlangen Fitness Osteoporosis Prevention Study. J Strength Cond Res. 2007 Feb;21(1):232-9. doi: 10.1519/R-20826.1.
PubMed 17313298Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.
PubMed 15746294Kemmler 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 15159265Kemmler W, Wildt L, Engelke K, Pintag R, Pavel M, Bracher B, Weineck J, Kalender W. Acute hormonal responses of a high impact physical exercise session in early postmenopausal women. Eur J Appl Physiol. 2003 Sep;90(1-2):199-209. doi: 10.1007/s00421-003-0874-7. Epub 2003 Jul 9.
PubMed 14504954Kemmler W, von Stengel S, Bebenek M, Kalender WA. Long-term exercise and risk of metabolic and cardiac diseases: the erlangen fitness and prevention study. Evid Based Complement Alternat Med. 2013;2013:768431. doi: 10.1155/2013/768431. Epub 2013 Jul 30.
PubMed 23983804
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on Fracture Risk, Bone Mineral Density and Falls in Postmenopausal Women. The Long-term Erlangen Fitness and Prevention Study.
- ClinicalTrials.gov ID
- NCT01177761
- Acronym / sponsor ID
- EFOPS / OFZ-EFOPS
- Conditions
- Osteoporosis, Osteopenia, Early Postmenopause
- Keywords
- Osteoporosis, exercise, fractures, Bone Mineral Density, CHD-risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Behinderten- und Versehrten-Sportverband Bayern e.V., Netzwerk Knochengesundheit e.V.
- Study start
- Oct 1998
- Primary completion
- Nov 2023 (actual)
- Study completion
- Nov 2023 (actual)
- First posted
- 9 Aug 2010 (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 study determines the long-term effect of exercise on osteoporotic fracture risk. Since actually no controlled supervised exercise study exceeds the time frame of 4 years, knowledge concerning the long-term effect of exercise on fractures and fracture-risk factors is scarce. Within the Erlanger Fitness and Osteoporosis Study (EFOPS, an ongoing controlled exercise study with currently 16 years of supervised exercise with 45-50 osteopenic, early-postmenopausal women in exercise and sedentary control group each, the investigators therefore focus on overall-fractures, Bone Mineral Density and falls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise | Active comparator | Procedure: physical exerciseendurance,balance, power, resistance type exercise |
| sedentary control | No intervention | –Subjects were instructed to do not relevantly change their lifestyle |
Who may qualify
- Ages
- 48 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- participants of the EFOPS-study,
- 12 years of exercise training according to the EFOPS-protocol (exercise).
Key exclusion criteria (4 listed)
- medication and diseases affecting bone metabolism,
- inflammable diseases,
- cardiovascular diseases,
- start of relevant physical exercise programs beside the EFOPS protocol.
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 |
|---|---|---|
| physical exerciseTwo sessions/week, 50 weeks/year over 12 years of high intensity exercise training | Procedure or surgery | exercise |
Primary outcome
overall-fractures (low-trauma)
Time frame: 16 year follow-up
As assessed by questionnaire and structured interview
Bone Mineral Density at Lumbar Spine and Proximal Femur
Time frame: 16 year follow-up
As assessed by Dual-Energy X-ray Absorptiometry (DEXA)
2 secondary outcomes
10-year coronary heart disease (CHD) risk
Time frame: 16 year follow-up
Metabolic Syndrome Z-Score
Time frame: 16 year follow-up
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 29 Nov 2023.
- Background: PubMed 21625881Kemmler W, von Stengel S, Bebenek M, Engelke K, Hentschke C, Kalender WA. Exercise and fractures in postmenopausal women: 12-year results of the Erlangen Fitness and Osteoporosis Prevention Study (EFOPS). Osteoporos Int. 2012 Apr;23(4):1267-76. doi: 10.1007/s00198-011-1663-5. Epub 2011 May 28.
- Background: PubMed 23190199Kemmler W, von Stengel S. Dose-response effect of exercise frequency on bone mineral density in post-menopausal, osteopenic women. Scand J Med Sci Sports. 2014 Jun;24(3):526-34. doi: 10.1111/sms.12024. Epub 2012 Nov 28.
- Results publication: PubMed 16096715Engelke K, Kemmler W, Lauber D, Beeskow C, Pintag R, Kalender WA. Exercise maintains bone density at spine and hip EFOPS: a 3-year longitudinal study in early postmenopausal women. Osteoporos Int. 2006 Jan;17(1):133-42. doi: 10.1007/s00198-005-1938-9. Epub 2005 Aug 12.
- Results publication: PubMed 17313298Kemmler W, Engelke K, von Stengel S, Weineck J, Lauber D, Kalender WA. Long-term four-year exercise has a positive effect on menopausal risk factors: the Erlangen Fitness Osteoporosis Prevention Study. J Strength Cond Res. 2007 Feb;21(1):232-9. doi: 10.1519/R-20826.1.
- Results publication: PubMed 15746294Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.
- Results publication: PubMed 15159265Kemmler 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.
- Results publication: PubMed 14504954Kemmler W, Wildt L, Engelke K, Pintag R, Pavel M, Bracher B, Weineck J, Kalender W. Acute hormonal responses of a high impact physical exercise session in early postmenopausal women. Eur J Appl Physiol. 2003 Sep;90(1-2):199-209. doi: 10.1007/s00421-003-0874-7. Epub 2003 Jul 9.
- Derived from this study: PubMed 23983804Kemmler W, von Stengel S, Bebenek M, Kalender WA. Long-term exercise and risk of metabolic and cardiac diseases: the erlangen fitness and prevention study. Evid Based Complement Alternat Med. 2013;2013:768431. doi: 10.1155/2013/768431. Epub 2013 Jul 30.
- homepage Institute of Medical Physics University of Erlangen-NürnbergLink provided by the sponsor.
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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.
Willi A Kalender, PHD, MD study chair
University of Erlangen-Nürnberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Osteoporosis and Osteopenia, 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 4 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 29 Nov 2023. 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. 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?
overall-fractures (low-trauma) (time frame: 16 year follow-up). The study lists 2 primary outcomes in all. 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 NCT01177761, which also lists 8 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 29 Nov 2023.