Back to resultsEffectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures
Primary Purpose
Fractures, Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
multidisciplinary osteoporosis prevention educational program
Sponsored by
About this trial
This is an interventional prevention trial for Fractures focused on measuring vitamin D, bone density
Eligibility Criteria
Inclusion Criteria: Age 60-70 years and living in southern Finland (Uusimaa region)
Sites / Locations
- Miina Sillanpää Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
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.
The control group will get information about osteoporosis through media and health care system.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00589615
First Posted
December 26, 2007
Last Updated
January 9, 2008
Sponsor
University of Helsinki
Collaborators
Miina Sillanpää Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00589615
Brief Title
Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures
Official Title
Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Helsinki
Collaborators
Miina Sillanpää Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Osteoporosis
Keywords
vitamin D, bone density
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
The control group will get information about osteoporosis through media and health care system.
Intervention Type
Behavioral
Intervention Name(s)
multidisciplinary osteoporosis prevention educational program
Intervention Description
The program includes individualized counseling aimed at improving diet, muscle strength, balance, and informing individuals about home hazards and the use of medicine.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 60-70 years and living in southern Finland (Uusimaa region)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matti J Välimäki, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miina Sillanpää Foundation
City
Helsinki
ZIP/Postal Code
00300 Helsinki
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
17158003
Citation
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.
Results Reference
background
PubMed Identifier
16015262
Citation
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.
Results Reference
background
Learn more about this trial
Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures
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