The Erlangen Fitness and Prevention Study (EFOPS).

Not Applicable

Completed

• Conditions: Osteopenia; Early Postmenopause; Osteoporosis
• Interventions: Procedure: physical exercise

• Registration Number: NCT01177761
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-10
• Study First Submitted: 2010-08-06
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Status Verified: 2023-11
• Primary Completion: 2023-11
• Study Completion: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise	physical exercise	endurance,balance, power, resistance type exercise

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density at Lumbar Spine and Proximal Femur	16 year follow-up	As assessed by Dual-Energy X-ray Absorptiometry (DEXA)
overall-fractures (low-trauma)	16 year follow-up	As assessed by questionnaire and structured interview

Secondary Outcome Measures

Name	Time	Method
10-year coronary heart disease (CHD) risk	16 year follow-up	As assessed by Framingham Risk Factor Calculator according to Wilson.
Metabolic Syndrome Z-Score	16 year follow-up	Metabolic Syndrome Z-Score Index according to Johnson

Trial Locations

Locations (1)

Institute of Medical Physics, University of Erlangen-Nurnberg; 🇩🇪 Erlangen, Bavaria, Germany