FracturesNCT00589615
Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures
A study testing multidisciplinary osteoporosis prevention educational program in people with Fractures and Osteoporosis, run by University of Helsinki at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 60 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fractures, Osteoporosis
- What is being tested?
- multidisciplinary osteoporosis prevention educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,181 participants
- Where
- 1 siteFinland
- Study dates
- Jan 1996to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-70 years and living in southern Finland (Uusimaa region)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fractures, Osteoporosis
- Being tested
- multidisciplinary osteoporosis prevention educational program
- Keywords
- vitamin D, bone density
- Medical subject headings
- Fractures, Bone, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary osteoporosis prevention educational programBehavioural
The program includes individualized counseling aimed at improving diet, muscle strength, balance, and informing individuals about home hazards and the use of medicine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: multidisciplinary osteoporosis prevention educational program |
| 2 | No intervention | The control group will get information about osteoporosis through media and health care system. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJan 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Miina Sillanpää Foundation
- Investigators
- Matti J Välimäki, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589615
- Sponsor's protocol ID
- 325/E05/01
- Other IDs
- Miina Sillanpää Foundation
- Status last verified
- Dec 2007
- First submitted
- 26 Dec 2007
- Last updated
- 10 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17158003Enattah 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.
PubMed 16015262
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures
- ClinicalTrials.gov ID
- NCT00589615
- Acronym / sponsor ID
- 325/E05/01
- Conditions
- Fractures, Osteoporosis
- Keywords
- vitamin D, bone density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,181 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Miina Sillanpää Foundation
- Study start
- Jan 1996
- First posted
- 10 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: multidisciplinary osteoporosis prevention educational programThe multidisciplinary osteoporosis prevention study started with a five-day program at a rehabilitation centre and will be followed by one-day group appointments twice. |
| 2 | No intervention | –The control group will get information about osteoporosis through media and health care system. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 60-70 years and living in southern Finland (Uusimaa region)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary osteoporosis prevention educational programThe program includes individualized counseling aimed at improving diet, muscle strength, balance, and informing individuals about home hazards and the use of medicine. | Behavioural | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2008.
- Background: PubMed 17158003Evio 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.
- Background: PubMed 16015262Enattah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matti J Välimäki, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary osteoporosis prevention educational program in people with Fractures and Osteoporosis, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00589615, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2008.