Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures

Osteoporosis Clinical Trial

Official title:

Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589615
• Other study ID #: 325/E05/01
• Secondary ID: Miina Sillanpää
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: January 9, 2008
• Start date: January 1996

Study information

• Verified date: December 2007
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The study will elucidate the effectiveness of an educational program in the prevention of osteoporosis and fractures. A random sample of the female population in Southern Finland (Uusimaa region) within the age group of 60-70 years was drawn from the population registry. From 1996 through 2000, 2181 women from the population register were recruited and randomly assigned to the intervention and to the control group. The subjects in the intervention group have been on a multidisciplinary program and the subjects in the control group received osteoporosis prevention information through the media and health care system. An end point is any fracture during the ten-year follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2181
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 60-70 years and living in southern Finland (Uusimaa region)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fractures
• Fractures, Bone
• Osteoporosis

Intervention

Behavioral:
• multidisciplinary osteoporosis prevention educational program
The program includes individualized counseling aimed at improving diet, muscle strength, balance, and informing individuals about home hazards and the use of medicine.

Locations

Country	Name	City	State
Finland	Miina Sillanpää Foundation	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	Miina Sillanpää Foundation

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Enattah N, Pekkarinen T, Välimäki MJ, Löyttyniemi E, Järvelä I. Genetically defined adult-type hypolactasia and self-reported lactose intolerance as risk factors of osteoporosis in Finnish postmenopausal women. Eur J Clin Nutr. 2005 Oct;59(10):1105-11. — View Citation

Eviö S, Pekkarinen T, Sintonen H, Tiitinen A, Välimäki MJ. The effect of hormone therapy on the health-related quality of life in elderly women. Maturitas. 2007 Feb 20;56(2):122-8. Epub 2006 Dec 8. — View Citation