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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Staedtler Stiftung, Nurnberg
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: August 11, 2012
Last verified: August 2012
History of Changes
  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 3 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 12 years of supervised exercise with 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 12 Year Follow-up of the Erlangen Fitness and Prevention Study.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • overall-fractures [ Time Frame: 12 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: 12 year follow-up ] [ Designated as safety issue: No ]
    As assessed by Dual-Energy X-ray Absorptiometry (DEXA)


Secondary Outcome Measures:
  • Number of falls and injurious falls [ Time Frame: 12 year follow-up ] [ Designated as safety issue: No ]
    As assessed by questionnaires and structured interview.

  • 10-year CHD risk [ Time Frame: 12 year follow-up ] [ Designated as safety issue: No ]
    As assessed by Framingham Risk Factor Calculator according to Wilson.


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
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
Staedtler Stiftung, Nurnberg
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:
homepage Institute of Medical Physics University of Erlangen-Nurnberg  This link exits the ClinicalTrials.gov site

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-EFOPS12
Study First Received: August 6, 2010
Last Updated: August 11, 2012
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
falls
CHD-risk

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

ClinicalTrials.gov processed this record on June 18, 2013