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

Tracking Information

First Received Date ^ICMJE

August 6, 2010

Last Updated Date

August 11, 2012

Start Date ^ICMJE

October 1998

Estimated Primary Completion Date

December 2023 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

overall-fractures [ Time Frame: Period between baseline and 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)

Change History

Complete list of historical versions of study NCT01177761 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Number of falls and injurious falls [ Time Frame: Recent 6 months before 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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoporosis
Osteopenia
Early Postmenopause

Intervention ^ICMJE

Procedure: physical exercise

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

Study Arm (s)

Active Comparator: exercise
endurance,balance, power, resistance type exercise

Intervention: Procedure: physical exercise
No Intervention: sedentary control
Subjects were instructed to do not relevantly change their lifestyle

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2023

Estimated Primary Completion Date

December 2023 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

48 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01177761

Other Study ID Numbers ^ICMJE

OFZ-EFOPS12

Has Data Monitoring Committee

Responsible Party

Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School

Study Sponsor ^ICMJE

University of Erlangen-Nürnberg Medical School

Collaborators ^ICMJE

Staedtler Stiftung, Nurnberg
Behinderten und Rehabilitations-Sportverband Bayern
Netzwerk Knochengesundheit e.V.

Investigators ^ICMJE

Study Chair:

Willi A Kalender, PHD, MD

University of Erlangen-Nürnberg Medical School

Information Provided By

University of Erlangen-Nürnberg Medical School

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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