- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00589615
Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures
January 9, 2008 updated by: University of Helsinki
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2181
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Helsinki, Finland, 00300 Helsinki
- Miina Sillanpää Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age 60-70 years and living in southern Finland (Uusimaa region)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 1
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.
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The program includes individualized counseling aimed at improving diet, muscle strength, balance, and informing individuals about home hazards and the use of medicine.
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No Intervention: 2
The control group will get information about osteoporosis through media and health care system.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Matti J Välimäki, MD, PhD, Helsinki University Central Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1996
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
January 9, 2008
First Posted (Estimate)
January 10, 2008
Study Record Updates
Last Update Posted (Estimate)
January 10, 2008
Last Update Submitted That Met QC Criteria
January 9, 2008
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 325/E05/01
- Miina Sillanpää Foundation
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.