16 Year Follow-up of the Erlangen Fitness and Prevention Study. (EFOPS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Behinderten und Rehabilitations-Sportverband Bayern
Netzwerk Knochengesundheit e.V.
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01177761
First received: August 6, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Osteopenia
Early Postmenopause
Procedure: physical exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Exercise on Fracture Risk, Bone Mineral Density and Falls in Postmenopausal Women. A 16 Year Follow-up of the Erlangen Fitness and Prevention Study.

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • overall-fractures (low-trauma) [ Time Frame: 16 year follow-up ] [ Designated as safety issue: No ]
    As assessed by questionnaire and structured interview

  • Bone Mineral Density at Lumbar Spine and Proximal Femur [ Time Frame: 16 year follow-up ] [ Designated as safety issue: No ]
    As assessed by Dual-Energy X-ray Absorptiometry (DEXA)


Secondary Outcome Measures:
  • 10-year coronary heart disease (CHD) risk [ Time Frame: 16 year follow-up ] [ Designated as safety issue: No ]
    As assessed by Framingham Risk Factor Calculator according to Wilson.

  • Metabolic Syndrome Z-Score [ Time Frame: 16 year follow-up ] [ Designated as safety issue: No ]
    Metabolic Syndrome Z-Score Index according to Johnson


Estimated Enrollment: 50
Study Start Date: October 1998
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: exercise
endurance,balance, power, resistance type exercise
Procedure: physical exercise
Two sessions/week, 50 weeks/year over 12 years of high intensity exercise training
No Intervention: sedentary control
Subjects were instructed to do not relevantly change their lifestyle

  Eligibility

Ages Eligible for Study:   48 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177761

Locations
Germany
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, Bavaria, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Behinderten und Rehabilitations-Sportverband Bayern
Netzwerk Knochengesundheit e.V.
Investigators
Study Chair: Willi A Kalender, PHD, MD University of Erlangen-Nürnberg Medical School
  More Information

Additional Information:
Publications:

Responsible Party: Wolfgang Kemmler, Professor Dr. Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01177761     History of Changes
Other Study ID Numbers: OFZ-EFOPS16
Study First Received: August 6, 2010
Last Updated: May 19, 2014
Health Authority: Germany: Ministry of Health
Germany: The Bavarian State Ministry of the Environment and Public Health

Keywords provided by University of Erlangen-Nürnberg Medical School:
Osteoporosis
exercise
fractures
Bone Mineral Density
CHD-risk

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 20, 2014