NCT00589615

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,181

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
12 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
Last Updated

January 10, 2008

Status Verified

December 1, 2007

First QC Date

December 26, 2007

Last Update Submit

January 9, 2008

Conditions

FracturesOsteoporosis

Keywords

vitamin Dbone density

Study Arms (2)

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

2

NO INTERVENTION

The control group will get information about osteoporosis through media and health care system.

Interventions

multidisciplinary osteoporosis prevention educational programBEHAVIORAL

The program includes individualized counseling aimed at improving diet, muscle strength, balance, and informing individuals about home hazards and the use of medicine.

1

Eligibility Criteria

Age60 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miina Sillanpää Foundation

Helsinki, 00300 Helsinki, Finland

Location

Related Publications (2)

  • Evio S, Pekkarinen T, Sintonen H, Tiitinen A, Valimaki MJ. The effect of hormone therapy on the health-related quality of life in elderly women. Maturitas. 2007 Feb 20;56(2):122-8. doi: 10.1016/j.maturitas.2006.06.009. Epub 2006 Dec 8.

    PMID: 17158003BACKGROUND

  • Enattah N, Pekkarinen T, Valimaki MJ, Loyttyniemi E, Jarvela 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. doi: 10.1038/sj.ejcn.1602219.

    PMID: 16015262BACKGROUND

MeSH Terms

Conditions

Fractures, BoneOsteoporosis

Condition Hierarchy (Ancestors)

Wounds and InjuriesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Matti J Välimäki, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 10, 2008

Study Start

January 1, 1996

Last Updated

January 10, 2008

Record last verified: 2007-12

Locations

FI(1)