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Completed

NCT Number: NCT01177761

The Erlangen Fitness and Prevention Study (EFOPS).

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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Key information

Conditions

Osteoporosis Behavior Bone Diseases Bone Diseases, Metabolic Early Postmenopause Fractures, Bone Metabolic Diseases Motor Activity Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Wounds and Injuries

Age range

48 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Medical Physics, University of Erlangen-Nurnberg

Erlangen, Bavaria, 91052, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Physical exercise

Procedure

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

Primary outcomes

  1. overall-fractures (low-trauma)

    Time frame: 16 year follow-up

    As assessed by questionnaire and structured interview

  2. Bone Mineral Density at Lumbar Spine and Proximal Femur

    Time frame: 16 year follow-up

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

Secondary outcomes

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

    Time frame: 16 year follow-up

    As assessed by Framingham Risk Factor Calculator according to Wilson.

  2. Metabolic Syndrome Z-Score

    Time frame: 16 year follow-up

    Metabolic Syndrome Z-Score Index according to Johnson

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Behinderten- und Versehrten-Sportverband Bayern e.V.
  • Netzwerk Knochengesundheit e.V.

Registry information

Official study title

Effects of Exercise on Fracture Risk, Bone Mineral Density and Falls in Postmenopausal Women. The Long-term Erlangen Fitness and Prevention Study.

Acronym: EFOPS

Important dates

Study start
1998
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2010
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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