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CompletedNCT01177761EFOPSUpdated Nov 29, 2023

The Erlangen Fitness and Prevention Study (EFOPS).

An interventional study of physical exercise in Osteoporosis, Osteopenia and Early Postmenopause, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 1 site in Germany. Open to female participants aged 48 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
48 Years and older
Sex
Female
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Study 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. 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.

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Conditions studied

  • Osteoporosis
  • Osteopenia
  • Early Postmenopause

Keywords

  • Osteoporosis
  • exercise
  • fractures
  • Bone Mineral Density
  • CHD-risk
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In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 50 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
48 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • participants of the EFOPS-study,
  • 12 years of exercise training according to the EFOPS-protocol (exercise).

Exclusion criteria

Exclusion Criteria:

  • medication and diseases affecting bone metabolism,
  • inflammable diseases,
  • cardiovascular diseases,
  • start of relevant physical exercise programs beside the EFOPS protocol.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    exercise

    endurance,balance, power, resistance type exercise

    Procedure: physical exercise

  • No intervention
    sedentary control

    Subjects were instructed to do not relevantly change their lifestyle

Interventions

  • Procedurephysical exercise

    Two sessions/week, 50 weeks/year over 12 years of high intensity exercise training

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What researchers measure

Primary outcomes

  1. overall-fractures (low-trauma)

    As assessed by questionnaire and structured interview

    Time frame: 16 year follow-up

  2. Bone Mineral Density at Lumbar Spine and Proximal Femur

    As assessed by Dual-Energy X-ray Absorptiometry (DEXA)

    Time frame: 16 year follow-up

Secondary outcomes

  1. 10-year coronary heart disease (CHD) risk

    As assessed by Framingham Risk Factor Calculator according to Wilson.

    Time frame: 16 year follow-up

  2. Metabolic Syndrome Z-Score

    Metabolic Syndrome Z-Score Index according to Johnson

    Time frame: 16 year follow-up

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Study locations

1 site
  • Institute of Medical Physics, University of Erlangen-Nurnberg
    Erlangen, Bavaria 91052, Germany
08

References and documents

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 21625881 ↗
  • Kemmler 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 23190199 ↗
  • Engelke 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 16096715 ↗
  • Kemmler 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 17313298 ↗
  • Stengel 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 15746294 ↗
  • 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 ↗
  • Kemmler 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 14504954 ↗
  • Kemmler 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01177761
Lead sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Behinderten- und Versehrten-Sportverband Bayern e.V., Netzwerk Knochengesundheit e.V.
Responsible party
Wolfgang Kemmler (Professor Dr. Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School) — Principal investigator
First posted
Aug 9, 2010
Start date
Oct 1998
Primary completion
Nov 2023
Completion
Nov 2023
Last update
Nov 29, 2023

Study contacts

Willi A Kalender, PHD, MD
study chair · University of Erlangen-Nürnberg Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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