Accidental FallsOFOSNCT01600547
Odense Fallers and Osteoporosis Study
An observational study of Accidental Falls and Osteoporosis, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Osteoporosis and falls occur with increasing frequency among the elderly. Osteoporosis and fall increases the risk of fracture. Falls in the elderly are associated with a high morbidity and mortality with potentially life-threatening consequences of falls including fractures. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Osteoporosis, Disability
- How many people
- 322 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to Dec 2014
- Phase
- Observational
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Study population: Consecutive patients attending the Odense University hospital falls clinic will be recruited to the study Two control groups will be recruited. A questionnaire will be sent to randomly selected community aged matched female controls.
Who may be able to join
- Women aged 65 years or over attending the falls clinic
- (There will be no upper age limit to recruitment).
- Those capable of giving Informed consent.
Who cannot join
- Patients under the age of 65 years.
- Men.
- Patients unwilling to give informed consent.
- Cognitively impaired people who are not capable of giving consent.
- Patients who are not mobile enough to be helped onto a DXA scan table with help
Trial locations and contacts
1 site in 1 country.
About this study
Osteoporosis and falls occur with increasing frequency among the elderly. Osteoporosis and fall increases the risk of fracture. Falls in the elderly are associated with a high morbidity and mortality with potentially life-threatening consequences of falls including fractures. Besides fracture fall may cause long term problems such as disability fear of falling and loss of independence. Today osteoporosis is diagnosed by bone scan of the hip and spine. The investigators want to investigate whether other more accessible and less expensive testing methods can be used to diagnose osteoporosis. Additionally, the investigators will examine the incidence of osteoporosis among the elderly in the municipality of Odense. Finally, the investigators would like to investigate the association between factors that can lead to falls and to investigate the performance of older and whether there are changes in functional ability over time.
Read the detailed description
Study Objectives
- To define the prevalence of osteoporosis in a falls clinic population, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.
- To evaluate the usefulness of peripheral bone scanning techniques in a falls clinic population.
- To determine the prevalence of vertebral fractures in a falls clinic population and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers
- To investigate functioning, disability, health related quality of life and perceived need for rehabilitation in a falls clinic population including variation in a one year period, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.
- Conditions
- Accidental Falls, Osteoporosis, Disability
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| fall clinic population | women, aged + 65 years | |
| control fallers | randomly selected community aged matched female controls with a fall episode | |
| control non fallers | randomly selected community aged matched female controls, with out fall episodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density using DXA of hip and spine regions (Hologic machine)
Measured: baseline
Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine)
Measured: baseline
Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine)
Measured: baseline
Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine)
Measured: baseline
Fall incidences
Measured: one year
Mental health state
Meausered by Mini Mental State Examination (MMSE)
Measured: one year
Health related quality of life
Self Reporting Questionnaire will be used
Measured: one year
Perceived need
Self Reporting Questionnaire
Measured: one year
Basis mobility
Time up and go, Chair stand, Bergs balance scale, Avlunds scale, gait speed and dual-task will be used
Measured: One year
Fear of falling
The Falls Efficacy scale - international will be used
Measured: One year
Muscle strength in upper and lower extremities
A dynamometer will be used
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Katja Thomsen, University of Southern Denmark
- Investigators
- Katja Thomsen, MD, Principal investigator, University of Southern DenmarkLisbeth Rosenbek Minet, ph.d., Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600547
- Sponsor's protocol ID
- s20110162
- Acronym
- OFOS
- Status last verified
- Dec 2014
- First submitted
- 8 May 2012
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thomsen K, Ryg J, Matzen L, Hermann AP, Masud T. Choice of osteoporosis guideline has important implications for the treatment decision in elderly women referred to a fall clinic. Dan Med J. 2014 Dec;61(12):A4980.
PubMed 25441734
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Odense Fallers and Osteoporosis Study
- ClinicalTrials.gov ID
- NCT01600547
- Acronym / sponsor ID
- OFOS / s20110162
- Conditions
- Accidental Falls, Osteoporosis, Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 May 2012 (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.
Osteoporosis and falls occur with increasing frequency among the elderly. Osteoporosis and fall increases the risk of fracture. Falls in the elderly are associated with a high morbidity and mortality with potentially life-threatening consequences of falls including fractures. Besides fracture fall may cause long term problems such as disability fear of falling and loss of independence. Today osteoporosis is diagnosed by bone scan of the hip and spine. The investigators want to investigate whether other more accessible and less expensive testing methods can be used to diagnose osteoporosis. Additionally, the investigators will examine the incidence of osteoporosis among the elderly in the municipality of Odense. Finally, the investigators would like to investigate the association between factors that can lead to falls and to investigate the performance of older and whether there are changes in functional ability over time.
Detailed description
Study Objectives
- To define the prevalence of osteoporosis in a falls clinic population, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.
- To evaluate the usefulness of peripheral bone scanning techniques in a falls clinic population.
- To determine the prevalence of vertebral fractures in a falls clinic population and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers
- To investigate functioning, disability, health related quality of life and perceived need for rehabilitation in a falls clinic population including variation in a one year period, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fall clinic population | – | –women, aged + 65 years |
| control fallers | – | –randomly selected community aged matched female controls with a fall episode |
| control non fallers | – | –randomly selected community aged matched female controls, with out fall episodes |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Consecutive patients attending the Odense University hospital falls clinic will be recruited to the study Two control groups will be recruited. A questionnaire will be sent to randomly selected community aged matched female controls.
Key inclusion criteria (3 listed)
- Women aged 65 years or over attending the falls clinic
- (There will be no upper age limit to recruitment).
- Those capable of giving Informed consent.
Key exclusion criteria (5 listed)
- Patients under the age of 65 years.
- Men.
- Patients unwilling to give informed consent.
- Cognitively impaired people who are not capable of giving consent.
- Patients who are not mobile enough to be helped onto a DXA scan table with help
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone mineral density using DXA of hip and spine regions (Hologic machine)
Time frame: baseline
Prevalence of vertebral fractures using instant vertebral assessment mode (IVA) of the DXA machine (Hologic machine)
Time frame: baseline
Bone mineral density of the phalanges using radiographic absorptiometry (Alara Metriscan machine)
Time frame: baseline
Broad band ultrasound attenuation of the heel using the heel ultrasound machine (Lunar Achilles machine)
Time frame: baseline
Fall incidences
Time frame: one year
Mental health state
Time frame: one year
Meausered by Mini Mental State Examination (MMSE)
Health related quality of life
Time frame: one year
Self Reporting Questionnaire will be used
Perceived need
Time frame: one year
Self Reporting Questionnaire
Basis mobility
Time frame: One year
Time up and go, Chair stand, Bergs balance scale, Avlunds scale, gait speed and dual-task will be used
Fear of falling
Time frame: One year
The Falls Efficacy scale - international will be used
Muscle strength in upper and lower extremities
Time frame: One year
A dynamometer will be used
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 8 Dec 2014.
- Derived from this study: PubMed 25441734Thomsen K, Ryg J, Matzen L, Hermann AP, Masud T. Choice of osteoporosis guideline has important implications for the treatment decision in elderly women referred to a fall clinic. Dan Med J. 2014 Dec;61(12):A4980.
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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.
Katja Thomsen, MD principal investigator
University of Southern Denmark
Lisbeth Rosenbek Minet, ph.d. principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Falls and Osteoporosis, run by University of Southern Denmark at 1 site in Denmark.
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 3 inclusion and 5 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 8 Dec 2014. 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 Denmark. 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.
What does the primary outcome measure?
Bone mineral density using DXA of hip and spine regions (Hologic machine) (time frame: baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01600547, which also lists 1 linked publication.
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 8 Dec 2014.