The Erlangen Fitness and Prevention Study (EFOPS).

Osteoporosis Clinical Trial

— EFOPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177761
• Other study ID #: OFZ-EFOPS
• Status: Completed
• Phase: N/A
• Start date: October 1998
• Est. completion date: November 2023

Study information

• Verified date: November 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 48 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Early Postmenopause
• Osteopenia
• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Germany	Institute of Medical Physics, University of Erlangen-Nurnberg	Erlangen	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Behinderten- und Versehrten-Sportverband Bayern e.V., Netzwerk Knochengesundheit e.V.

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Engelke K, Kemmler W, Lauber D, Beeskow C, Pintag R, Kalender WA. Exercise maintains bone density at spine and hip EFOPS: a 3-year longitudinal study in early postmenopausal women. Osteoporos Int. 2006 Jan;17(1):133-42. doi: 10.1007/s00198-005-1938-9. Epu — View Citation

Kemmler W, Engelke K, von Stengel S, Weineck J, Lauber D, Kalender WA. Long-term four-year exercise has a positive effect on menopausal risk factors: the Erlangen Fitness Osteoporosis Prevention Study. J Strength Cond Res. 2007 Feb;21(1):232-9. doi: 10.15 — View Citation

Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention — View Citation

Kemmler W, von Stengel S, Bebenek M, Engelke K, Hentschke C, Kalender WA. Exercise and fractures in postmenopausal women: 12-year results of the Erlangen Fitness and Osteoporosis Prevention Study (EFOPS). Osteoporos Int. 2012 Apr;23(4):1267-76. doi: 10.1007/s00198-011-1663-5. Epub 2011 May 28. — View Citation

Kemmler W, von Stengel S. Dose-response effect of exercise frequency on bone mineral density in post-menopausal, osteopenic women. Scand J Med Sci Sports. 2014 Jun;24(3):526-34. doi: 10.1111/sms.12024. Epub 2012 Nov 28. — View Citation

Kemmler W, Wildt L, Engelke K, Pintag R, Pavel M, Bracher B, Weineck J, Kalender W. Acute hormonal responses of a high impact physical exercise session in early postmenopausal women. Eur J Appl Physiol. 2003 Sep;90(1-2):199-209. doi: 10.1007/s00421-003-08 — View Citation

Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall-fractures (low-trauma)	As assessed by questionnaire and structured interview	16 year follow-up
Primary	Bone Mineral Density at Lumbar Spine and Proximal Femur	As assessed by Dual-Energy X-ray Absorptiometry (DEXA)	16 year follow-up
Secondary	10-year coronary heart disease (CHD) risk	As assessed by Framingham Risk Factor Calculator according to Wilson.	16 year follow-up
Secondary	Metabolic Syndrome Z-Score	Metabolic Syndrome Z-Score Index according to Johnson	16 year follow-up

External Links

•   homepage Institute of Medical Physics University of Erlangen-Nürnberg