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

This study has been completed.

First Received: December 26, 2007 Last Updated: January 9, 2008 History of Changes

Sponsors and Collaborators:	Helsinki University Miina Sillanpää Foundation
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00589615

Purpose

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.

Condition	Intervention
Fractures Osteoporosis	Behavioral: multidisciplinary osteoporosis prevention educational program

MedlinePlus related topics: Fractures Osteoporosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures

Further study details as provided by Helsinki University:

Enrollment:	2181
Study Start Date:	January 1996

Arms	Assigned Interventions
1: Active Comparator The multidisciplinary osteoporosis prevention study started with a five-day program at a rehabilitation centre and will be followed by one-day group appointments twice.	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.
2: No Intervention The control group will get information about osteoporosis through media and health care system.

Eligibility

Ages Eligible for Study:	60 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589615

Locations

Finland
Miina Sillanpää Foundation
Helsinki, Finland, 00300 Helsinki

Sponsors and Collaborators

Helsinki University

Miina Sillanpää Foundation

Investigators

Principal Investigator:

Matti J Välimäki, MD, PhD

Helsinki University

More Information

Publications:

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.

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.

Responsible Party:	Helsinki University Central Hospital ( Matti Välimäki, MD, PhD )
Study ID Numbers:	325/E05/01, Miina Sillanpää Foundation
Study First Received:	December 26, 2007
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00589615 History of Changes
Health Authority:	Finland: Ethics Committee

Keywords provided by Helsinki University:

vitamin D
bone density

Study placed in the following topic categories:

Vitamin D
Musculoskeletal Diseases
Vitamins
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009